ReGelTec, Inc.

Injectable hydrogels for people suffering from chronic low back pa...


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ReGelTec: Fast Facts

This Problem
Really Hits Home 

Low back pain (LBP) is the most common cause of chronic pain.

It is estimated to cost the United States more than $50 billion every year in direct healthcare costs, lost wages and productivity.

Think about that for a moment -- $50 billion.

The First True Solution

As people age, the nucleus material in their intervertebral disc degenerates, causing the disc to flatten and expand radially.

Then the disc impinges on the spinal cord, causing immense pain.

HYDRAFIL can be injected into the disc with a small needle to "pump up" the disc and alleviate the pain.

The polymer's properties have been designed to mimic the function of the natural nucleus and has been shown to restore the biomechanical properties of a degenerated disc.

CAUTION: The ReGelTec Hydrafil System is a Medical Device limited by Federal (United States) and European Law exclusively for clinical investigation.

How It Works

HYDRAFIL™ is injected into the nucleus of an intervertebral disc with a small (17 gauge) needle as a viscous solution ~65C .

This is only possible with the company’s patented new formulation which is heat treated prior to injection.

Because the polymer is injected as a viscous solution, the disc can be filled to a predetermined height or pressure and forms a single solid implant within the disc as it cools to body temperature.

Because the injected volume is easily controlled, the device can be tuned each time to appropriately restore the nucleus function.

Traction & Accomplishments

Meet The Team

Bill Niland

  • Former CEO of Harpoon Medical, a startup in Baltimore, MD with a unique Mitral Valve repair technology that was successfully sold to Edwards Lifesciences for $250M ($100M upfront & $150M milestones in 4.5 years
  • Founder of Vapotherm, Inc. (VAPO); also served as the firm's Chairman and Chief Business Officer (has treated >2M patients and went public 2018)
  • Founder and CEO of Advanced Sleep Technologies, which grew into National Sleep Technologies ("NST") and sold to Vital Signs
  • Inventor on 15 patents

Dr. Anthony M. (Tony) Lowman

  • Provost at Rowan University and former Dean of the College of Engineering
  • Sold GeliFlex, previous hydrogel company, to Depuy/Synthes
  • Elected to the National Academy of Inventors
  • MIT Technology Review: Top 100 Scientific Inventors under 35
  • He has 20+ US and worldwide patents issued, secured >$20M grant funding and, published more than 100 refereed journal articles and book chapters

Peter Wilson

  • 25+ years of experience of medical device experience prior to ReGelTec, most recently as a cofounder and the VP of R&D at Harpoon Medical.
  • Began his career at Boston Scientific where he worked on peripheral stents and vena cava filters
  • Has also worked as an early employee with Micrus Endovascular (acquired by J&J), Vivant Medical (acquired by Covidien), Emphasys Medical (acquired by Pulmonix), and Harpoon Medical (acquired by Edwards Lifesciences)

Zita Yurko, RAC

  • 20+ years of experience in the area of medical device regulatory affairs and quality systems
  • VP of RA/QS at Harpoon Medical where she was responsible for securing ISO 13485 certification and gaining CE mark for the company’s MDD Class III device
  • Experience with FDA pre-submission meetings, and supported the approval for all EU clinical sites where the Harpoon device was studied

Mark Collins, CPA

  • Co-founder and CFO of Harpoon Medical, Inc.
  • Broad background in accounting, information systems, human resources, purchasing, manufacturing and customer service
  • 30 years of experience in the manufacturing environment including medical device, industrial and automotive industries
  • Worked with Bill Niland for >15 years, starting as controller of Vapotherm

Eric Brewer, Ph.D

  • Polymer chemist at ReGelTec
  • Full-time lecturer and Chair of Innovations and External Partnerships at Rowan University in Glassboro, New Jersey
  • Former Associate Scientist at Merck Research Lab’s Biopharmaceutics division

Peter Boyd, JD, MBA

  • Business development executive with a scientific, business and legal background
  • Cofounder of Harpoon Medical responsible for legal and business development activities including fundraising and the company’s structured exit to Edwards Lifesciences
  • Has worked with Mr. Niland and Mr. Collins in various capacities over the last fifteen years at Harpoon Medical and Vapotherm

Dr. Thomas P. Schaer, VMD

  • Accomplished research and preclinical services executive with 20+ years of experience and success in new product introduction and product development lifecycle management
  • Successfully identifies new information and generates opportunities to create evidenced-based strategies that advance innovation and develop new business

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