Cara Therapeutics Reports Positive Results from Phase II Trial of Novel Peripheral Kappa Agonist, CR845, in Acute Post-Operative Pain

Statistically significant decreases in morphine use and pain intensity demonstrated in 24-hour period after surgery with pre- and post-operative administration of CR845

SHELTON, Conn., June 11, 2012 -- Cara Therapeutics, Inc. today announced positive results from a Phase II study for the treatment of acute post-operative pain with its novel, peptide-based, peripherally-acting kappa opioid agonist, CR845.  The study successfully met its primary endpoint which measured the effect of CR845 treatment on reducing the amount of rescue opioid analgesics used in the 24 hour period post-surgery, as well as secondary endpoints which evaluated the ability of CR845 to reduce post-operative pain as assessed by a number of standard measures, including pain intensity differences (PIDs), summed pain intensity differences (SPIDs), and patient evaluation of study medication over the post-surgical 24-hour period.

The Phase II study was a double-randomized, double-blind, placebo-controlled study of intravenous CR845 (0.04mg/kg/dose) in women undergoing a laparoscopic hysterectomy. The trial was conducted at 22 sites across the U.S., and enrolled 203 patients who were randomized into four treatment arms:  (1) both a pre-and a post-operative dose of CR845; (2) a single pre-operative dose of CR845; (3) a single post-operative dose of CR845; and (4) both pre- and post-operative placebo.  Patients receiving both a pre- and post-operative dose of CR845 achieved the study's primary endpoint by exhibiting a statistically significant reduction (~33%, p<0.05) of morphine use over 24 hours compared to the placebo group. This patient group also exhibited an approximately two-fold (~100%) increase in their calculated 24 hour PID(0-24) (p=0.002) and SPID(0-24) (p=0.003) values compared to placebo-treated subjects.  Significant 24-hour analgesic effects were also seen in patients receiving a single post-operative dose of CR845 where SPID(0-24) values (p=0.014) increased by more than 50% when compared to placebo.  Global evaluation of study medication by all patients indicated a significant treatment effect of CR845 (p=0.006), with 80% of subjects receiving a pre- and post-operative dose of CR845 rating the drug as good-to-excellent. Pre- and/or post-surgical dosing of CR845 was safe and well tolerated, and was generally associated with a decreased incidence of the common opioid-related side effects of nausea, vomiting and pruritus. Importantly, CR845 did not produce any of the CNS-related effects seen with centrally-acting kappa opioid agonists.

"The results of this Phase II trial have further confirmed the robust analgesic efficacy of CR845 in this acute post-operative setting," said James B. Jones, M.D., Pharm. D., Chief Medical Officer of Cara Therapeutics. "Moreover, these data have established the clear clinical advantage of dosing CR845 before and after surgery in significantly reducing the severity of patient pain and the need for opioid rescue medication in the first 24 hours post-surgery.

"Dr. Tong J. Gan, study Principal Investigator, Professor of Anesthesiology & Vice Chair for Clinical Research at Duke University commented: "Postoperative pain is still poorly managed and there is a need for novel anti-inflammatory and analgesic drugs for perioperative pain management. These results indicate that this new class of anti-inflammatory/analgesic can potentially be used in a multimodal analgesic strategy, including preoperative dosing, to improve postoperative pain and reduce the need for morphine and other opioids."

"This trial with CR845 has clearly demonstrated that a peripherally-selective kappa opioid agonist is a fundamentally new and viable option for the treatment of acute post-op pain," said Derek Chalmers, Ph.D., President and CEO at Cara.  "We have now treated over 300 patients with CR845 and have not seen any of the psychiatric side effects that have precluded the development of centrally-acting kappa opioid agonists.  Additionally, we now have strong evidence of the clinical benefit of pre-operative dosing of CR845 which is a key differentiating aspect of our product as NSAIDs are no longer used in this setting due to the increased risk of bleeding." 

About CR845

CR845 is a highly selective, peptide-based, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus.  In addition to the development of an intravenous (IV) formulation of CR845 for hospital use, Cara has recently completed a successful Phase I study of an oral capsule formulation of CR845 suitable for clinical development for the treatment of post-operative pain following hospital discharge, as well as chronic inflammatory pain conditions. CR845 has been found to be safe and well tolerated in the more than 300 patients dosed to date, with no cases of dysphoric reactions or hallucinations that have been reported with centrally-acting, non-peptidic kappa opioid agonists. 

About Cara Therapeutics

Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara's current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara's strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.

For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, Inc. +1-203-567-1500

SOURCE: Cara Therapeutics, Inc.

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AXIOS™ Stent and Delivery System Study Demonstrates Successful Treatment of Pancreatic Pseudocysts and Acute Cholecystitis
Peer-Reviewed Paper Validates Promise of New Transenteric Therapy


May 15, 2012, Mountain View, CAXlumena, Inc. announces the publication of a scientific paper describing the first human study of the AXIOS™ Stent and Delivery System. The article, entitled “Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage” appeared in the April issue of Gastrointestinal Endoscopy – the leading journal for advances in endoscopy.

The research reports technical and clinical success using the AXIOS Stent to treat 15 pancreatic pseudocyst and 5 acute cholecystitis patients. All the pseudocysts and cholecystitis symptoms resolved and did not recur during the 9 month follow-up period. There were no complications during stent placement or removal.

Pancreatic pseudocysts are painful and potentially dangerous fluid-filled sacs most often resulting from pancreatitis. They can be treated surgically, percutaneously or endoscopically. Cholecystitis, or inflammation of the gallbladder, is usually alleviated by surgically removing the gallbladder. Patients who cannot undergo surgery have only the uncomfortable option of having a percutaneous (external) drain inserted into their gallbladder.

“This study demonstrates the promise of the AXIOS Stent,” says Takao Itoi, MD of Tokyo Medical University Hospital and the paper’s lead author. “We were able to successfully treat these very sick patients endoscopically and enable them to avoid more invasive procedures.”

The stent provides a new approach for gallstone removal. “Two patients in the trial had gallstones. In one of these the stones came out on their own through the stent and in the other we were able to remove the stones. This is a unique and potentially clinically important development,” adds Dr. Itoi.

Also interesting is that one cholecystitis patient in the study refuses to have the stent removed. “She had undergone frequent and repeated interventions for her cholecystitis symptoms without any lasting benefit. Since the stent was placed 18 months ago the symptoms have not returned and so the patient has insisted we leave the stent in place,” says Dr. Itoi.


The stent is delivered under endoscopic guidance in four steps using a specially-designed catheter. All stents were successfully placed with no problems.

Kenneth Binmoeller, MD, a co-author, is the Medical Director of the Interventional Endoscopy Service (IES) at California Pacific Medical Center and Xlumena’s Chief Medical Officer. “We saw no complications related to the stent in this study and it performed just as we had expected. The 10 mm stent opening provided effective drainage and remained patent throughout the study. Flanges on the ends of the stent held it in place. One stent placed into a pseudocyst did migrate into stomach, though this occurred after the pseudocyst had resolved.”

Research on the use of the AXIOS Stent to treat cholecystitis has been on-going. A poster describing the successful treatment of 11 patients will be reported at the upcoming DDW 2012 meeting in San Diego. As with the current study, once the stent was placed the patients had immediate relief of their cholecystitis symptoms.


The AXIOS Stent and Delivery System is currently being sold in Europe for use in pancreatic pseudocysts. The AXIOS Stent is an investigational device (limited by federal law to investigational use) and is not commercially available in the United States. An Investigational Device Exemption Study is being conducted to determine if the stent can safely and effectively treat pancreatic pseudocysts.

About Xlumena, Inc.
Xlumena, Inc. is the leader in the development of image-guided therapeutic endoscopy products, specializing in advanced implants and devices for therapeutic endoscopists. Collaborating with top physicians in the field, Xlumena focuses on technologies that advance therapy to the next level. These innovations may enable numerous minimally invasive transenteric therapeutic interventions, helping transform complex surgeries into lower cost and less complicated outpatient procedures.


For more information on Xlumena or AXIOS please contact 650-961-9900 or info@xlumena.com


Xlumena and AXIOS are trademarks of Xlumena, Inc.

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Cara Therapeutics Licenses Novel Kappa Opioid Agonist, CR845, to Chong Kun Dang Pharmaceutical Corporation For South Korean Market


SHELTON, CT and Seoul, Korea, May 3rd, 2012
--Cara Therapeutics, Inc and Chong Kun Dang Pharmaceutical Corporation (CKD Pharm) today announced that they have entered into a licensing agreement that provides CKD Pharm with the exclusive rights to develop and market Cara’s lead analgesic drug candidate, CR845, in the Republic of Korea. Under the terms of the agreement, Cara will receive an up-front payment, including an equity investment, and is eligible to receive further milestone payments related to pre-defined clinical and regulatory events in Korea and the U.S., as well as royalties on Korean sales of any marketed products containing CR845.


CR845 is a highly selective, peptide-based, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain. Cara is developing an intravenous formulation of CR845 in the U.S. for the treatment of acute post-operative pain. The Company recently completed a 200-patient Phase II trial with data expected in Q2, 2012. Earlier this year, Cara successfully completed a Phase I trial with an oral capsule formulation of CR845 which demonstrated a mean oral bioavailability of 16% across all patient groups and peripheral kappa opioid receptor activation at all doses tested as measured by a standard biomarker.


“CKD Pharm’s excellence in clinical development, marketing, and sales in South Korea makes them an ideal partner for the commercialization of CR845 within this territory,” said Derek Chalmers, CEO of Cara Therapeutics. “As we continue to advance both the IV and oral formulations of CR845 in the U.S., this transaction will allow Cara to expand its clinical and commercial activities into this growing marketplace."

CKD Pharm vice chairman, Jung-Woo Kim, Ph.D., commented, “We expect Cara’s innovative CR845 compound to be successfully developed under our partnership and be subsequently well positioned to perform in the Korean market in the near future.”


About CR845
In a previous randomized, placebo-controlled Phase II study, CR845 demonstrated evidence of analgesic efficacy when administered as a single intravenous dose to women following laparoscopic hysterectomy. In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of post-operative opioids (narcotics) and showed a significant reduction in the incidence of post-operative nausea and vomiting. A multicenter, double-blind, randomized, placebo-controlled 200-patient Phase II trial to evaluate the efficacy and safety of intravenous CR845 when administered both pre and post-operatively in women undergoing laparoscopic hysterectomy has completed enrollment, with data expected in Q2, 2012.


About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara's pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.


About Chong Kun Dang Pharm Corp
CKD Pharm, headquartered in Seoul, and employing over 1400 people in Sales and Marketing, Production, and R&D, is one of Korea’s leading pharmaceutical companies, with 2011 revenues of over $390 million. In addition to analgesics, CKD markets ethical products in the cardiovascular, anti-infective, and gastrointestinal disease therapeutic areas, among others. The Company is engaged in the development, manufacture, distribution, import and export of pharmaceutical finished products, raw materials, as well as medical devices, among others. CKD’s core products include remedies for high blood pressure and high cholesterol, immunosuppressive drugs, analgesics and remedies for cold. It also produces antitumor agents, antibiotics, digestives, circulation agents, respiratory agents, remedies for endocrine diseases, remedies for skin diseases, and others.


Contact Information:
Chong Kun Dang Pharm Corp
368 Chungjeong-ro 3-ga
Seodaemun-gu
Seoul, Korea, 120-756
Korea, Republic of
Phone: 82-2-2194-0315
Fax: 82-2-2194-0449
www.ckdpharm.com


Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara's strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.


SOURCE: Cara Therapeutics, Inc.

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Cara Therapeutics Successfully Completes Phase I Study With Oral Formulation of Its Novel Kappa Opioid Receptor Agonist, CR845


- robust bioavailability and pharmacologic activity seen with oral formulation of peptide-based Kappa Opioid Agonist -

Shelton, CT - April 3, 2012 -- Cara Therapeutics, Inc. today announced the successful completion of a first-in-man Phase I clinical trial of an oral formulation of its peptide-based, peripherally-restricted kappa opioid receptor agonist, CR845. The trial was a single-center, double-blind, placebo-controlled study to evaluate the pharmacokinetics (PK), safety and pharmacodynamics of CR845 in healthy volunteers. An intravenous formulation of CR845 is currently in clinical development for the treatment of acute postoperative pain. The company recently completed enrollment of a 200-patient Phase II study with topline data expected in Q2, 2012.

In the oral Phase I study, a total of 50 male volunteers were randomized to receive either placebo or one of four single ascending doses of an enteric-coated, capsule formulation of CR845. The study demonstrated a mean oral bioavailability of 16% across all groups under fasting conditions, with peak and total exposures proportional to each dose. Peripheral kappa opioid receptor activation was seen at all doses tested as measured by a standard biomarker. Additionally, orally administered CR845 appeared to be safe and generally well tolerated across all doses tested and, as seen with the IV formulation, did not produce any of the dysphoric or psychomimetic side effects that have precluded the clinical development of centrally acting kappa opioid agonists.

"We are very impressed with the bioavailability and bioactivity exhibited by this oral formulation of CR845,” said Dr. Frederique Menzaghi, V.P. of R&D at Cara Therapeutics. "The results of this Phase I trial have confirmed appropriate pharmacokinetic, pharmacodynamic and safety characteristics of this formulation and provide a basis for further clinical development.”

“As we continue the development of IV CR845 for in-hospital treatment of postoperative pain, we are encouraged to confirm the potential viability of an oral formulation to provide a step-down therapy for continued pain relief following discharge,” said Derek Chalmers, CEO of Cara Therapeutics. “These oral data also open up a much broader market opportunity for CR845 in the treatment of chronic pain for which there continues
to be a very large unmet need for new and safer treatment modalities.”

About CR845
CR845 is a highly selective, peptide-based, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain. In a previous randomized, placebo-controlled Phase II study, CR845 demonstrated evidence of analgesic efficacy when administered as a single intravenous dose to women following laparoscopic hysterectomy. In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of post-operative opioids (narcotics) and showed a significant reduction in the incidence of post-operative nausea and vomiting. A multicenter, double-blind, randomized, placebo-controlled 200-patient Phase II trial to evaluate the efficacy and safety of intravenous CR845 when administered both pre and post-operatively in women undergoing laparoscopic hysterectomy has completed enrollment with topline data expected in Q2, 2012.

About Oral CR845 & Unigene

In general, clinical development of orally active peptide drugs has been limited by their physicochemical properties (i.e., high polar surface area and limited membrane permeability) and their susceptibility to enzyme breakdown. To overcome this challenge, and enhance the oral bioavailability of CR845, the compound was formulated by Unigene Laboratories using their peptide formulation technology under a Manufacturing and Clinical Supply Agreement.

About Unigene Laboratories

Unigene has designed and developed a validated, proprietary oral formulation delivery technology, Peptelligence™ with proven success in a Phase 3 clinical trial evaluating oral calcitonin and a Phase 2 proof-of-concept study with a positive outcome evaluating an oral parathyroid hormone analog. In addition, the Company currently has nine feasibility studies ongoing or completed across a broad spectrum of therapeutic areas.

About Cara Therapeutics

Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara's pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara's strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.

SOURCE: Cara Therapeutics, Inc.

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St. Joseph’s Improving Post-Cath Patient Comfort with Self-Sealing Arteriotomy Procedure

 

A new, non-implant option for femoral artery closure after cardiac catheterization

 

STOCKTON, CA, April 2, 2012 – A revolutionary femoral artery access procedure is making closure more comfortable for cardiac catheterization (cath) patients. Each year, more than one million cardiac caths are performed in the United States, and in most of these procedures, physicians access the arteries that provide blood supply to the heart through femoral artery in the groin. At the end of every case, patients are left with a substantial hole in the artery which can command significant effort to close and in the process cause patients much pain from closure methods and discomfort of having to lie still for hours at a time. In an effort to eliminate these issues, St. Joseph’s Medical Center is now performing the Self-Sealing Arteriotomy, or Arstaotomy™ Procedure at the beginning of their catheterizations which provides rapid hemostasis resulting with earlier time to sitting-up and quicker ambulation for their patients.

 

My patients who have had previous caths are amazed that they are able to sit up so soon, often times within 30 minutes after their procedure,” said Ramin Manshadi, MD. “I’ve been able to get these patients up and walking around in just an hour after the procedure, versus the 5-6 hours they had to lie flat after previous procedures. Patients are much more comfortable post-procedure.”

One such patient is Susan Campbell, a 64-year old woman from Stockton. Susan had one previous cath procedure before the most recent, which included the Self-Sealing Arteriotomy, performed by her beloved cardiologist Dr. Manshadi.

 

“I was up out of bed and moving around extremely quickly after my procedure,” said Campbell. “I had no pain, no problems; plus, I really enjoyed my stay at the hospital! It doesn’t get better than that.”

 

The Self-Sealing Arteriotomy Procedure creates a unique, very low angle access into the femoral artery through which the catheterization procedure is performed. Once the procedure is complete, shorter and gentler manual compression is applied resulting in a secure closure with no foreign body implants – thus eliminating the risk of infections and other complications related to traditional vascular implants.

 

“Getting my patients up and walking around sooner means they can get back to their lives sooner,” said Gurinder Grewal, MD. “Plus, the fact that there is no implant means that nothing is left behind, reducing the risk of complications. Anytime I can make the procedure and recovery easier and more comfortable for my patients, I strive to do so.”

 

About Vascular Closure 

There are two methods of closing the femoral artery after cardiovascular procedures – manual compression and vascular closure implants. Manual compression entails up to 30 minutes of firm manual pressure applied directly to the access site, which is often painful for the patient, followed by 4 to 8 hours of flat bed rest in a hospital recovery room. Physicians frequently choose to use a vascular closure implant (VCI) as an alternative to manual compression because it can stop the bleeding more quickly. However, despite the benefits of VCIs, many patients find that deployment of a VCI can be painful and physicians are hesitant to leave an implant behind as foreign bodies can cause infection and other complications.

 

About Arstasis, Inc.

Arstasis, Inc., headquartered in Redwood City, California, is a medical device manufacturer dedicated to bringing innovative arterial access devices to cardiologists, interventional radiologists, their staffs, and patients. Detailed information about the AXERA™ Access Device and the Self-Sealing Arstaotomy procedure is available at www.arstasis.com.

 

About St. Joseph’s Medical Center

St. Joseph’s Medical Center is a not-for-profit, fully accredited, regional hospital with 359 beds, a physician staff of over 400, and more than 2,400 employees. St. Joseph's specializes in cardiovascular care, comprehensive cancer services, and women and children’s services including neonatal intensive care (NICU). St. Joseph’s Medical Center is the largest hospital, as well as the largest private employer in San Joaquin County. In addition to being nationally recognized as a quality leader, St. Joseph’s is consistently chosen as the “most preferred hospital” by local consumers. Founded in 1899 by Fr. William O’Connor and administered by the Dominican Sisters of San Rafael, St. Joseph's continues to lead the region in medical innovation as well as ongoing clinical research, developing tomorrow's advancements, today. St. Joseph’s Medical Center is committed to delivering compassionate, high-quality, affordable healthcare services with special attention to the poor and underserved. In 2011, St. Joseph’s provided over $44 million in charity care, community benefits, and unreimbursed patient care. St. Joseph’s Medical Center is a member of Dignity Health (formerly Catholic Healthcare West), the fifth largest health system in the country with a network of more than 150 ancillary care sites and 40 acute care hospitals across Arizona, California, and Nevada. For more information, please visit our website at www.StJosephsCares.org.

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Greenville, SC and Somerset, NJ – December 2, 2011  --   Biomerix Corporation and KIYATEC announced today a relationship through which high value, high impact microphysiological systems research takes a major leap forward with the launch of 3DKUBE™ - Biomerix 3D Scaffold™ Preloads.  By combining 3D scaffolds and perfusion 3D cell culture plasticware in a preassembled, single-use disposable format, the companies have achieved an industry first.  The new product will allow 3D cell culture researchers to “just add cells” via perfusion seeding into each Biomerix 3D Scaffold™ housed inside KIYATEC’s 3DKUBE™ 3D Cell Culture Plasticware.  Researchers can now economically and conveniently access the huge benefits of actively perfusing their 3D cell-scaffold constructs without having to make or manipulate scaffolds.

The preloaded product incorporates the Biomerix 3D Scaffold™, a non-resorbable polycarbonate polyurethane-urea scaffold matrix structurally designed to mimic the nature and function of the extracellular matrix (ECM).  Each scaffold has an interconnected 3D network of cells and pores with 90-95% accessible void content, and provides an in vitro cell culture environment that promotes cellular organization, cell-matrix and cell-cell interactions, cellular proliferation and ECM synthesis.   To create the new product, the Biomerix 3D Scaffold™ disks are preloaded into a KIYATEC 3DKUBE™ in an “Independent Chambers” configuration and benefit from its leading combination of universality, features and cost-effectiveness.

KIYATEC CEO Matt Gevaert, PhD will take the stage to provide more details in Denver, Colorado on Tuesday, December 6th.  He will discuss this and other product innovations during the company’s Exhibitor Showcase workshop at the 2011 Annual Meeting of the American Society for Cell Biology.   KIYATEC’s Exhibitor Showcase is sponsored by Sigma Life Sciences, a leading life science and high technology company with $2.3 billion in sales of chemicals and laboratory equipment in 2010.  Sigma distributes KIYATEC’s 3D cell culture products.  The new product will also be featured at KIYATEC’s exhibit booth over the course of the three-day meeting.

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Fremont, CA,  January 24, 2011 --  Biomerix Corporation announced today that it has received CE Mark approval for its REVIVE™ soft tissue repair mesh allowing for the marketing of REVIVE in all European Union member (EU) states. REVIVE received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2009.

REVIVE is constructed of the Biomerix Biomaterial™, a proprietary, biointegrative synthetic tissue scaffold. This unique structure is designed to play a role similar to that of the body’s extracellular> matrix, supporting organized tissue ingrowth. The device is designed for repair and reinforcement in a variety of soft tissue procedures such as inguinal hernias.

Over 700,000 inguinal hernia repair procedures are performed annually in Europe. Inguinal hernias occur when soft tissue, usually part of the intestines, protrudes through a weak point or tear in the lower abdominal wall. Synthetic mesh is commonly used to reinforce the repair and support the surrounding tissue. REVIVE is designed to facilitate robust tissue ingrowth, while minimizing the scarring response typically associated with implantation of a mesh. Mesh contraction and intense scarring can lead to persistent groin pain. Initial feedback from users of REVIVE has confirmed excellent ease of use and conformability to the anatomy. The soft, pliable nature of the mesh easily adapts to the anatomy allowing for easy delivery, positioning and fixation of the mesh.

“This latest approval represents another important milestone in Biomerix’s plans to develop innovative products based on its proprietary materials and capabilities,” said Kenneth G. Hayes, President and CEO of Biomerix Corporation. “REVIVE will be distributed in the EU by Medline Industries pursuant to our exclusive distribution agreement.”

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Fremont, CA,  June 15, 2009 -- Biomerix Corporation, a medical technologies company developing products using its novel Biomerix Biomaterial™, a three-dimensional scaffold for biointegrative tissue repair, announced today that it has received an ISO 13485 Certificate of Registration. Issued by the British Standards Institution (BSI), the certification indicates that Biomerix has successfully implemented a quality system that conforms to the exacting International Organization for Standardization (ISO) standards for medical devices. ISO is one of the key regulatory requirements for a CE Mark in the European Union as well as other international markets. The certification applies to the Fremont, CA location which designs, manufactures and distributes finished medical devices and the Somerset, NJ location which manufactures the Biomerix Biomaterial.

ISO 13485 is an internationally recognized standardization system which defines standards for the design, development, production and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective devices. Achievement of ISO 13485:2003 demonstrates Biomerix Corporation's dedication to continuously improve product quality by providing finished medical devices and polymer components that consistently meet customer and regulatory requirements.

"This certification represents a major milestone for Biomerix Corporation and demonstrates our unwavering commitment to producing high-quality devices for our customers. Meeting the ISO standards speaks to our belief in our quality management system and is an important step towards commercialization abroad," commented Kenneth G. Hayes, President and Chief Executive Officer of Biomerix Corporation .

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Fremont, CA,  February 26, 2009 -- Biomerix Corporation announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market REVIVE(TM). Constructed using the Biomerix Biomaterial(TM), REVIVE acts as a tissue scaffold facilitating rapid tissue ingrowth and can be utilized in a variety of soft tissue repair procedures, including the repair of inguinal hernias.

With more than 700,000 procedures per year, inguinal hernia repair is one of the most common surgeries in the U.S. (1) Hernia repair typically involves the use of a mesh to reinforce and support the surrounding tissue. REVIVE is designed to minimize the scarring response that results from implantation of a mesh, which studies have shown can lead to persistent groin pain in 30% of patients at one year. (2) Clinical feedback has confirmed REVIVE offers excellent conformability to the defect and ease of handling. (3 )"Biomerix is poised for rapid growth over the course of the next few years. The company plans to launch numerous products across a range of therapeutic areas by capitalizing on its novel Biomerix Biomaterial platform technology. REVIVE is specifically designed to support tissue remodeling by enhancing the soft tissue wound healing process and thereby improves clinical outcomes," stated Kenneth G. Hayes, President and Chief Executive Officer of Biomerix Corporation.

The company has initiated a market launch of REVIVE in the U.S. through a small direct sales force and plans to expand the group over time as additional products are brought to market.

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Shelton, CT,  January 12, 2009 -- Cara Therapeutics, Inc. today announced that it is initiating a Phase II clinical trial of its long-acting peripheral kappa opioid agonist, CR845. The Phase II multi-center, double-blind, placebo-controlled trial will be conducted in the United States and will evaluate the analgesic efficacy and safety of intravenous CR845 during the post-operative period in women following laparoscopic-assisted hysterectomy. The trial is expected to enroll 120 patients, who will be randomly selected for treatment with one of two doses of CR845 or placebo. Results from the study are expected in the second half of 2009.


The Company also expects to initiate a Phase I study of an oral formulation of CR845 later in 2009.

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Fremont, CA, January 12, 2009--  ARYx Therapeutics Inc., a biopharmaceutical company, today announced further results from a Phase 2b clinical trial testing the safety and efficacy of its oral anti-arrhythmic therapy, ATI-2042, in patients with atrial fibrillation. This follows the December 18, 2008 press release reporting that ATI-2042 reached statistical significance at its primary end point in the two highest of three doses tested. Those results are now reinforced by these additional findings indicating, in part, that patients in the study quickly returned to their pre-treatment level of atrial fibrillation once the treatment ended. The complete safety results from this study are still not finalized and are expected by the end of March 2009.

"These additional results broaden our confidence about the effectiveness of ATI-2042. We believe these incremental data provide additional clinical evidence that ATI-2042 does not accumulate in the body which is known to be a major liability with the treatment of choice, amiodarone," stated Dr. Paul Goddard, chairman and chief executive officer of ARYx Therapeutics. "Our product has been designed to be as effective as amiodarone in a broad atrial fibrillation patient population, including those with congestive heart failure, but without its known safety problems. These additional Phase 2b results should support our efforts to find the right partner for the full development and eventual commercialization of ATI-2042."

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Fremont, CA, August 22, 2008--  ARYx Therapeutics Inc., a biopharmaceutical company, today announced the results of a Phase 2b clinical trial testing the safety and efficacy of its prokinetic agent, ATI-7505, in patients with chronic idiopathic constipation. The clinical trial, conducted by Procter and Gamble Pharmaceuticals (P&G), was designed to enroll 400 patients evaluating four doses of the agent compared to placebo. As announced last month, the study was terminated early after only 214 patients had been enrolled, as a result of the termination of the collaboration between ARYx and P&G.

"In spite of the early termination of the study, ATI-7505 achieved statistical significance at the study's primary endpoint in the 80 mg twice daily dose. In addition, all doses tested demonstrated a clinically meaningful increase in spontaneous bowel movements over baseline compared to placebo after one week of treatment," said Dr. Paul Goddard, Chief Executive Officer and Chairman of ARYx. "From a tolerability perspective, ATI-7505 improved patients' ability to experience spontaneous bowel movements with virtually no reports of diarrhea or nausea from the patients in this trial."

The clinical trial was a Phase 2b, randomized, placebo-controlled study of ATI-7505 in patients with chronic idiopathic constipation conducted at 42 trial sites in 5 countries. Patients were treated for 4 weeks and the primary efficacy endpoint was the improvement in the total number of spontaneous bowel movements (SBM) during the first 7 days after randomization compared to placebo. Patients were randomized to either placebo or doses of ATI-7505 of 20 mg twice a day (bid), 40 mg bid, 80 mg bid, or 120 mg bid. Randomization was balanced amongst all treatment arms. SBM was defined as a bowel movement occurring without the need for a laxative or enema within the preceding 24 hours. Safety assessments were conducted on every patient enrolled.

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Shelton, CT, August 5, 2008 -- Cara Therapeutics, Inc. today announced completion of a Phase I clinical trial for its second-generation, peripherally acting kappa opioid agonist, CR845, under development for thetreatment of acute and chronic pain. The drug candidate was safe and well-tolerated after intravenous infusion, and resulted in plasma levels of CR845 expected to be associated with clinical analgesic activity. In addition, CR845 infusion triggered a quantitative endocrine biomarker of peripheral kappa opioid receptor activation at the lowest dose tested.

The Phase Ia single-center clinical trial evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of CR845 in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female volunteers. CR845 was shown to be safe at all doses investigated, with no reports of serious side effects or adverse central nervous system activity. Linear, dose-proportional increases in systemic exposure to CR845 were observed. Low doses of CR845 resulted in plasma levels at or above the plasma levels of drug expected to be associated with clinical analgesic efficacy. 

The Company plans to advance its intravenous formulation of CR845 into Phase II trials later in 2008. Based on the demonstrated safety, tolerability, and bioactivity of this formulation in Phase I, Cara will continue to develop its oral formulation of CR845 for advancement into Phase I.

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Shelton, CT, July 24, 2008 -- Cara Therapeutics, Inc. announced today that it had closed on $12.3 million of additional funding to its original $24 million Series C financing which was completed in 2007. The round was led by new investor, Devon Park Bioventures, and included participation by Connecticut Innovations. Previous investors participating in the round included; Ascent Biomedical Ventures, Mitsubishi International Corporation and Wistar Morris. In conjunction with the financing, Dr. Christopher Moller, General Partner at Devon Park Bioventures, will join Cara's Board of Directors. The additional funds will be used primarily for further clinical development of both intravenous and oral formulations of Cara's second generation peripherally-selective kappa opioid agonist, CR845.

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Shelton, CT, July 22, 2008 -- Cara Therapeutics, Inc. announced today that The United States Patent and Trademark Office has issued U.S. Patent No. 7,402,564 entitled "Synthetic Peptide Amides" under its Accelerated Examination Program. The application was filed on November 12, 2007 and covers Cara's second generation, peripherally-selective kappa opioid receptor agonist compounds. These compounds include CR845, currently completing a Phase I clinical trial and in development for injectable and oral delivery for the treatment of acute and chronic pain of visceral, inflammatory and neuropathic origin, and for the treatment of pruritis (itch), a common disorder associated with several diseases and conditions.

In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in reducing pain of inflammatory, neuropathic and visceral origin. The analgesic and anti-inflammatory effects of CR845 lasted for up to 18 hours after a single dose. CR845 was active after intravenous, subcutaneous, or oral administration. Preclinical studies also indicate that CR845 possesses anti-itch properties. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus), impair breathing or elicit signs of addiction in animal models. CR845 is currently completing Phase Ia studies.

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Sunnyvale, CA, June 24, 2008 -- Spinal Kinetics, a leader and innovator in advanced generation artificial disc technology, today announced that it has successfully completed patient enrollment in it’s M6-C artificial cervical disc U.S. Feasibility Study.

The Feasibility Trial results will be used to gain FDA clearance to initiate a broader U.S. pivotal trial to study the safety and efficacy of the M6-C artificial cervical disc in a larger population of patients with degenerative disc disease of the cervical spine. “Overall we were extremely pleased with the intra-operative performance of the M6 cervical disc, as well as the simplicity and ease of implanting the device during the study,” states Thomas Dimmig, MD, Principal Study Investigator from Triangle Orthopedic Associates in Durham, NC. “The natural design characteristics of this artificial disc may provide added clinical benefit for our disc replacement patients by more accurately replicating the biomechanical motion of the natural disc we remove. We will be closely assessing our patient outcomes to gain further insight to the benefits of this unique design.” Founded in 2003, Spinal Kinetics is a privately-held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine.

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Raynham, MA, November 13, 2007 -- DePuy Spine, Inc., in partnership with Johnson & Johnson Development Corporation (JJDC), today announced that they will provide $5 million in Series C equity financing to Biomerix Corporation, a medical technology company developing novel devices in orthopedic, endovascular, and neurovascular medicine.  The investment will be used to advance the company’s development programs including development of a new annulus repair implant following lumbar discectomy.

The annular implant utilizes a novel, proprietary biomaterial, the Biomerix Reticulated Matrix, a biocompatible, biodurable polyurethane scaffold which has been shown to support tissue growth in animals and may reduce the risk of recurrent disc herniation and continued degeneration of the affected disc.

Approximately 300,000 discectomy procedures are performed in the United States and up to 10 percent of patients require additional surgeries to correct reherniation.  During a discectomy, the surgeon removes the portion of the spinal disc that is herniated and protruding into the spinal canal.

“We continue to invest in new technologies that have the potential to dramatically improve patient outcomes in spinal interventions,” said Gary P. Fischetti, President, DePuy Spine.  “Biomerix has an innovative technology that we believe can make a real difference for spine surgeons and their patients and we look forward to our continued collaboration with them.”

“We are pleased with the support we received from DePuy Spine and JJDC.  This will enable us to take our product development efforts to the next level with a partner committed to innovation that improves outcomes,” said Steven Hochberg, Chief Executive Officer, Biomerix. 

DePuy Spine, a Johnson & Johnson company, has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years.  The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies.

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Fremont, CA, November 7, 2007 --  ARYx Therapeutics Inc., announced today that it has priced its initial public offering of 5,000,000 shares of its common stock at a price of $10.00 per share. All shares are being offered by ARYx Therapeutics. In addition, ARYx Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares to cover over-allotments, if any. ARYx Therapeutics common stock will trade on the NASDAQ Global Market under the symbol "ARYX."

The underwriters of this offering are Morgan Stanley & Co. Incorporated acting as sole book runner and lead manager, and CIBC World Markets Corp., Jefferies & Company, Inc. and Leerink Swann LLC, Inc. acting as co-managers.

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Fremont, CA, August 30, 2007 --   ARYx Therapeutics Inc.,  announced today that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission for a proposed initial public offering of shares of its common stock. All of the shares in the proposed offering will be sold by ARYx Therapeutics.

The underwriters of the offering will be Morgan Stanley & Co. Incorporated acting as sole book runner and lead manager and CIBC World Markets Corp., Jefferies & Company, Inc. and Leerink Swann & Co., Inc. acting as co-managers. The number of shares to be offered and the price range for the offering have not yet been determined.

The offering will be made only by means of a prospectus. When available, a copy of the preliminary prospectus relating to the offering may be obtained from Morgan Stanley & Co. Incorporated by emailing prospectus@morganstanley.com or by contacting the prospectus department at 180 Varick Street, New York, NY 10014 Attn: Prospectus Department.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

ARYx Therapeutics is a biopharmaceutical  company focused on developing a portfolio of internally discovered product candidates designed to eliminate known safety issues associated with well-established, commercially successful drugs. ARYx uses its RetroMetabolic Drug Design™  technology to design structurally unique molecules that retain the efficacy of these original drugs but are metabolized through a potentially safer pathway to avoid specific adverse side effects associated with these compounds.  ARYx currently has three products in Phase 2 clinical trials: ATI-7505 for the treatment of various gastrointestinal disorders, ATI-5923 for the treatment of patients at risk for the formation of dangerous blood clots, and ATI-2042 for the treatment of atrial fibrillation.

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Tarrytown, NY, November 28, 2006 -- Cara Therapeutics, Inc. announced today that it had closed on $19 million of its Series C financing. New investors participating in the round include MVM Life Science Partners and Alta Biopharma Partners, as well as previous investors Ascent Biomedical Ventures. In conjunction with the financing, Dr. Stephen Reeders, Managing Partner of MVM Life Science Partners, and Ed Hurwitz, Director of Alta Partners, will join Cara's Board of Directors. Dr. Stephen Reeders commented "Over the last twenty years there has been little innovation in treating pain. There is a big gap in the choices available to clinicians between moderately efficacious OTC analgesics and centrally accting opiates with serious side effects. We believe that Cara Therapeutics is developing novel drugs to fill this gap."

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Cincinnati, OH, and Fremont, CA, July 11, 2006 -- Procter & Gamble Pharmaceuticals Inc., a division of The Procter & Gamble Company (NYSE: PG) and ARYx Therapeutics Inc., a private drug discovery and development company, today announced a strategic alliance under which P&G will develop and commercialize ARYx's novel drug, ATI-7505, for the treatment of gastrointestinal disorders such as gastrointestinal reflux disease (GERD) and gastroparesis (delayed emptying of the stomach).

Under the terms of the agreement, which remains subject to clearance under the Hart-Scott-Rodino Improvements Act, ARYx will grant P&G rights to the worldwide development and commercialization of ATI-7505 in exchange for a $25 million upfront fee, milestone payments, and royalties on product sales. In addition, ARYx has an option to co-develop and co-promote ATI-7505. In total, payments could reach $435 million over the life of the project, including $250 million that could be earned prior to commercialization. These payments are contigent upon the successful completion of specified development, regulatory, and commericialization goals. ARYx will receive royalties, with the rate escalating upon the achievement of varying sales targets. No other financial terms of the agreement were disclosed.

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Fremont, CA, February 7, 2006 -- ARYx Therapeutics Inc., a private drug discovery and development company, announced today that it has completed a $30.4 million Series E financing led by Ascent Biomedical Ventures. The Company plans to use the funds to continue developing its three clinical programs, ATI-2042, ATI-7505 and ATI-5923 through to proof of concept Phase 2 data. The Company expects to seek partnerships for each of its products upon successful proof of concept.

In addition to Ascent Biomedical Ventures, the Company's existing investors, including MPM Capitol, Nomura Phase4 Ventures, OrbiMed, Merlin BioMed, JAFCO Life Science Invesments, Scottish Widows Investment Partnership, Montreux Equity Partners and Novel Bioventures, participated in the fundraising.

ARYx anticipates that through the application of its proprietary retrometabolic chemistry approach, the Company can address and resolve safety issues associated with well-established and commercially successful drugs. Based on this approach, ARYx has advanced three products into human clinical trials. ATI-7505, a treatment for gastroesophageal reflux disease (GERD) and gastroparesis, and ATI-2042, a treatment for atrial fibrillation, are both in Phase 2. ATI-5923 is an oral anti-coagulant therapy currently in Phase 1 clinical testing.

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Tarrytown, NY, January 5th, 2006 -- Cara Therapeutics, Inc. announced today that it had entered into a worldwide licensing agreement with ALZA Corporation, a Johnson & Johnson company, for Cara's novel peripherally-acting pain drug candidate, CR665. Cara has successfully completed a Phase 1a clinical trial with an intravenous formulation of CR665 and the collaboration will focus on further clinical development of this formulation, as well as the development of additional formulations of this compound incorporating ALZA technologies. "We believe that ALZA's and Johnson & Johnson's proven expertise in drug development and marketing in the analgesia and anti-inflammatory sector will provide an optimum path for the worldwide clinical development and commercialization of CR665," stated Dr. Derek Chalmers, Cara's President and CEO.

Under the terms of the agreement, Cara received an upfront payment and will be eligible to receive pre-determined clinical and regulatory milestone payments. Cara is also eligible to receive royalties on sales of all marketed products incorporating the compound, as well as an option to co-promote intravenous products in the U.S. Cara will be supported by J&J and ALZA for further development of CR665 -- including an IV formulation for post-operative and nursing home applications, and formulations that would allow outpatient and primary care pain treatments in large indications such as rheumatoid arthritis and inflammatory bowel syndrome.

The Company also announced that it had closed $4.7 million of Series B funding in December 2005. Ascent Biomedical Ventures participated in the round along with existing individual investors. The Series B funding will be used to advance internal development programs for additional pain and inflammation drug candidates.

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New York, NY, February 3, 2005 -- Biomerix Corporation announced today that it received 510(k) clearance from the U.S. FDA for its first device, the Biomerix Vascular Occlusion Device (VOD). The VOD is based on the Company's novel, proprietary biomaterial, the Biomerix Reticulated Matrix, a biocompatible, biodurable polyurethane scaffold which has been demonstrated to support tissue ingrowth in preclinical studies. Biomerix is a medical technology company developing novel devices for endovascular, neurovascular, and orthopedic medicine. Founded in late 2001, Biomerix is currently developing four products addressing an aggregate worldwide market opportunity of approximately $2 billion.