Palyon Medical

Palyon Medical and CORE Manufacturing Announce Strategic Partnership

Valencia, CA - Palyon Medical Corporation and CORE Manufacturing LLC have entered into a strategic partnership for the manufacturing of Palyon’s line of implantable drug delivery pumps.

Palyon, a developmental stage company, has a pump portfolio that includes programmable devices for maximum clinical flexibility and constant flow devices for lower cost steady drug delivery. CORE is an ISO 13485, ISO 9001 and FDA approved manufacturer of implantable devices. Under this new partnership, CORE Manufacturing will provide manufacturing services, procurement coordination and dual quality control oversight, greatly reducing Palyon’s time to market introduction.

“CORE brings a level of clinical manufacturing experience that will greatly streamline our process and allow our researchers and engineers to focus on developing the next generation of devices, such as an implantable insulin pump,” said Michael Sember, Palyon CEO. “Having CORE’s production facility in such close proximity to us will allow for enhanced efficiency, reduced manufacturing coordination costs and speed our path to market.”

Palyon’s inventive implantable infusion pump platform will offer highly accurate drug delivery rates and incorporate unique safety features including the only sensor-based feedback flow control, refill error detection capability, a non-motorized pumping mechanism that is less susceptible to wear and tear, catheter occlusion detection and a highly favorable MRI profile.

"CORE Manufacturing is honored to partner with Palyon. CORE is uniquely qualified to develop and manufacture the lineup of Palyon’s active implantable devices. This partnership will allow both companies to leverage their core competencies," said Joel Hirsch, President of CORE Manufacturing.

 

About Palyon

Palyon Medical Corporation, headquartered in Southern California, is a privately held medical device company focused on creating innovative treatment systems to alleviate symptoms of chronic pain, spasticity, diseases of the central nervous system and chronic metabolic diseases. Palyon’s mission is to provide the market with the broadest range of implantable infusion devices that offer an unparalleled feature set to address a broad range of unmet medical needs. For more information visit www.palyonmedical.com.

 

About CORE Manufacturing, LLC

Located in Valencia, CA, CORE Manufacturing is an ISO 13485, ISO 9001, and FDA approved manufacturer of implantable, minimally invasive, and peripheral medical devices. Capabilities include: rapid-turn prototyping, full turnkey device-level assembly, sterilization and testing.

 

Media Contact:

Palyon Medical Corp: Michael Sember msember@palyoncorp.com, (661) 705-5601

CORE Manufacturing LLC: Joel Hirsch jhirsch@core-manufacturing.com, (661) 621-6200

Luis Malave Joins Palyon Corporation as CEO

NEW YORK, August 24, 2010 -- Palyon Corporation (Palyon), a New York-based medical device company focused on the treatment of chronic pain, spasticity and other acute and chronic diseases, has named Luis Malave as its new Chief Executive Officer. Malave was previously Chief Operating Officer of Insulet Corporation, a public company that develops pumps for insulin delivery. He succeeds David Present, M.D., who continues as Palyon’s Chairman.

“I am very excited to join Palyon and think this role is a natural next step in my career,” said Malave. “I believe the technology supporting Palyon’s platform for delivery of multiple drugs will lead to very meaningful benefits for patients and physicians, and I look forward to leading the company toward that potential.”

Palyon is developing a state-of-the-art Implantable Drug Delivery System (IDDS), which delivers therapeutics directly into the spinal canal. The initial application of the technology is in the treatment of patients suffering from chronic pain. Chronic pain, defined as pain lasting 6 months or longer, affects 76 million Americans (more than heart disease, diabetes and cancer combined). Up to 20 percent of chronic pain patients do not respond to conventional medical management, such as oral medications and physical therapy, and may become candidates for interventional pain management therapies such as Palyon’s IDDS.Due to its inherent flexibility as a delivery platform, the IDDS can be used to deliver therapeutics to treat both acute diseases, such as cancer, and chronic diseases including diabetes and multiple sclerosis.

“We are pleased to welcome Luis to Palyon,” said Dr. Present, Palyon Chairman. “His deep experience in this space, from R&D to operations, makes him the ideal candidate to guide Palyon to the next level. He will be a tremendous asset to our company.”

 

Biography – Luis Malave

Malave has more than 23 years in the medical device sector and served as Insulet’s Chief Operating Officer since January 2007. Previously, he was Insulet’s Senior Vice President of Research, Development and Engineering. He began his medical device career as a software engineer in the instrument division of Medtronic. From Medtronic, he moved to Minimed as one of its first employees and served in a number of positions, ultimately as Director of Engineering before moving to Insulet. Malave earned his bachelor’s degree from the University of Minnesota, and his MBA from the University of Maryland.

 

About Palyon Corporation

Palyon Corporation is a medical device company based in New York City developing technologies for the treatment of chronic pain, spasticity and other acute and chronic diseases.

For additional information, contact:
Doug Fechter, Chief Financial Officer
(212) 333-2082
dfechter@palyoncorp.com

Insulet Announces Departure of Chief Operating Officer

BEDFORD, MA--(Marketwire - August 17, 2010) - Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced that Chief Operating Officer Luis Malave has resigned effective August 31, 2010 to become the Chief Executive Officer of Palyon Medical. On an interim basis, Insulet's operations function will continue to be jointly managed by Ruthann DePietro, Insulet's Vice President of Quality & Regulatory Affairs and Kevin Schmid, Vice President of Operations and Engineering, both of whom will report directly to Duane DeSisto, the Company's Chief Executive Officer.

"We thank Luis for his eight years of commitment and guidance in helping to establish Insulet as a leader in the diabetes industry," commented Mr. DeSisto. "During his tenure at the Company, Luis formed a talented and experienced team that has been instrumental in scaling-up Insulet's manufacturing processes. Luis was responsible for building our partnership with Flextronics, which has driven our manufacturing capacity and efficiency such that we can now produce more than 1,000,000 pods per quarter. With the next generation OmniPod System nearing submission to the Food and Drug Administration, I am confident, given our experienced management team in place, that we are well positioned for continued revenue growth and gross margin expansion. We appreciate Luis' contributions and wish him success in his new role."

 

Forward-Looking Statement

This press release contains forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs or strategies regarding the future, including those related to its expected revenue and gross margin, management structure, manufacturing capacity and new product launches. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on it. There can be no assurance that future developments affecting it will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the Company's dependence on the OmniPod System; Insulet's ability to increase customer orders and manufacturing volumes; adverse changes in general economic conditions; impact of healthcare reform legislation; Insulet's inability to raise additional funds in the future on acceptable terms or at all; potential supply problems or price fluctuations with sole source or other third-party suppliers on which Insulet is dependent; international business risks; Insulet's inability to obtain adequate coverage or reimbursement from third-party payors for the OmniPod System and potential adverse changes in reimbursement rates or policies relating to the OmniPod; potential adverse effects resulting from competition with competitors; technological innovations adversely affecting the Company's business; potential termination of Insulet's license to incorporate a blood glucose meter into the OmniPod System; Insulet's ability to protect its intellectual property and other proprietary rights; conflicts with the intellectual property of third parties, including claims that Insulet's current or future products infringe the proprietary rights of others; adverse regulatory or legal actions relating to the OmniPod System; failure of Insulet's contract manufacturers or component suppliers to comply with FDA's quality system regulations, the potential violation of federal or state laws prohibiting "kickbacks" or protecting patient health information, or any challenges to or investigations into Insulet's practices under these laws; product liability lawsuits that may be brought against Insulet; reduced retention rates; unfavorable results of clinical studies relating to the OmniPod System or the products of Insulet's competitors; potential future publication of articles or announcement of positions by physician associations or other organizations that are unfavorable to Insulet's products; the expansion, or attempted expansion, into foreign markets; the concentration of substantially all of Insulet's manufacturing capacity at a single location in China and substantially all of Insulet's inventory at a single location in Massachusetts; Insulet's ability to attract and retain key personnel; Insulet's ability to manage its growth; fluctuations in quarterly results of operations; risks associated with potential future acquisitions; Insulet's ability to generate sufficient cash to service all of its indebtedness; the expansion of Insulet's distribution network; Insulet's ability to successfully maintain effective internal controls; and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 9, 2010 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

 

About Insulet Corporation

Insulet Corporation is an innovative medical device company dedicated to improving the lives of people with diabetes. The Company's OmniPod Insulin Management System is a revolutionary, discreet and easy-to-use insulin infusion system that features two easy-to-use parts with no tubing and fully-automated cannula insertion. Through the OmniPod System, Insulet seeks to expand the use of continuous subcutaneous insulin infusion (CSII) therapy among people with insulin-dependent diabetes. Founded in 2000, Insulet is based in Bedford, MA.

 

Contact:

Stephanie Marks for Insulet Corporation
Email: ir@insulet.com
877-PODD-IR1 (877-763-3471)

Nextech Venture participates in the $24m financing of Palyon Medical

Zurich, Switzerland - Palyon Medical, Inc., a New York-based medical device company, has raised $24m in Series A financing.

The proceeds will be used to finance a multi-site clinical study and to commercialise Palyon's programmable, implantable drug delivery system, which delivers targeted doses of pain medication directly to the spinal area. Baird Venture Partners led the round, with Hambrecht & Quist Capital Management. Fountain Healthcare Partners, BB Biotech Ventures, Cross Atlantic Partners, Arcus Ventures. Nextech Venture also participated in the transaction.

Palyon focuses on the treatment of chronic pain, spasticity and other neurological diseases. Chronic pain, which is defined as pain lasting six months or longer, affects 76 million Americans, according to the company.

David Present, MD, CEO of Palyon, said, "We are very excited to team up with Baird Venture Partners and this group of investors to take Palyon to the next level. We believe that our unique technology platform has led to the development of a next-generation device that will offer meaningful benefits to patients and physicians."

Michael Liang, principal at Baird Venture Partners, added, "There is a significant opportunity for Palyon to participate in and expand this underserved market. We are excited to help facilitate that progress by leading this successful financing syndicate, and believe that the oversubscribed demand for participation in this round speaks to the opportunity."

Palyon Medical Corporation Secures $21 Million Series A Investment

Palyon’s Programmable Implantable Drug Delivery System Intended for Management of Chronic Pain, Spasticity and other Neurological Diseases

NEW YORK, APRIL 29, 2009 – Palyon Medical Corporation (Palyon), a New York-based medical device company, announced today it has raised $21 million in Series A financing. The proceeds will be used to finance a multi-site clinical study and to commercialize Palyon’s programmable implantable drug delivery system, which delivers targeted doses of pain medication directly to the spinal area. Baird Venture Partners led the round, with Hambrecht & Quist Capital Management, Fountain Healthcare Partners, BB Biotech Ventures, Cross Atlantic Partners and Arcus Ventures also participating in the transaction.

Palyon focuses on the treatment of chronic pain, spasticity and other neurological diseases. Chronic pain, which is defined as pain lasting six months or longer, affects 76 million Americans -- more than heart disease, diabetes and cancer combined. Up to 20 percent of chronic pain patients do not respond to conventional medical management, such as oral medications and physical therapy, and may become candidates for interventional pain management therapies such as Palyon’s programmable implantable drug delivery system.

“We are very excited to team up with Baird Venture Partners and this group of investors to take Palyon to the next level,” said David Present, M.D., CEO of Palyon. “We believe that our unique technology platform has led to the development of a next-generation device that will offer meaningful benefits to patients and physicians.”

“There is a significant opportunity for Palyon to participate in and expand this underserved market,” said Michael Liang, Ph.D., Principal at Baird Venture Partners. “We are excited to help facilitate that progress by leading this successful financing syndicate, and believe that the oversubscribed demand for participation in this round speaks to the opportunity.”

In addition, Glen Kashuba will join as a new member of Palyon’s Board of Directors. Kashuba is President of Biomet Trauma and Biomet Spine and was previously President of Johnson & Johnson's Codman Neuroscience division, where he was responsible for overseeing the company’s neuromodulation efforts. Michael Liang, Ph.D, of Baird Venture Partners, Daniel Omstead, Ph.D., of Hambrecht & Quist Capital Management, and Aidan King of Fountain Healthcare Partners will also join the Board.

Rockport Venture Securities, LLC, a wholly-owned subsidiary of Rockport Venture Partners, acted as placement agent in connection with the offering.

 

About Palyon Medical Corporation

Palyon Medical Corporation is a medical device company developing technologies for the treatment of chronic pain, spasticity and other neurological diseases.

 

For additional information, contact:

David Present, M.D., CEO
212-333-2050
dpresent@palyonmedical.com