Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Regenerative medicine gets on a profitable roll

August 17, 2010 By Mass High Tech: The Journal of New England Technology

After getting off to a false start in the 1990s, the field of regenerative medicine has been reborn over the past decade.

Now, several New England companies are showing that regenerative medicine — generally defined as therapy that uses living cells to repair the body — is more than just promising science. It can also be profitable.

“Regenerative medicine is certainly an industry that is very commercially viable,” said Lee Buckler, managing director at Cell Therapy Group, a regenerative medicine consulting firm in Vancouver, B.C. “But it’s been a long and arduous path.”

Probably no company knows that better than Canton-based Organogenesis Inc. The company achieved a major milestone for the field of regenerative medicine in 1998 when it won U.S. Food and Drug Administration approval for Apligraf, a cell-based product that helps to heal venous leg ulcers and diabetic foot ulcers.

But four years later, the company was in bankruptcy court after failing to overcome numerous challenges, such as finding a cost-effective way to produce and transport the product; getting enough adoption from health-care providers; and getting proper reimbursement rates.

Organogenesis, which re-launched in 2004, has now solved those issues and became profitable around 2008, said CEO Geoff MacKay. Some of the issues simply took time to figure out — trial and error — while it also took time for the health-care system to become familiar with the novel treatment, MacKay said.

To date, 250,000 patients have been treated with Apligraf, and the company is now in the middle of a $60 million expansion of its manufacturing facilities in Canton. The new facilities are expected to open in late 2013.

MacKay refers to the current stage as “round two” for both his company and for regenerative medicine as a whole. “We still have the great science, but we’re able to build a business measured on revenue growth and profitability,” he said.

And as more companies are able to base their businesses on financial fundamentals and not just science, that will spawn greater confidence among investors in the field, MacKay said.

Another New England company is turning regenerative therapy into profits, Buckler said. Westport, Conn.-based Advanced BioHealing Inc. has commercialized a bio-engineered skin substitute, Dermagraft, used to treat diabetic foot ulcers.

Meanwhile, Cambridge-based Pervasis Therapeutics Inc. is on track to have its first product on the market by 2014, said CEO Fred Chereau. The product, Vascugel, is a cell-based therapy that aims to enhance blood vessel repair. The product recently won the go-ahead from the FDA to begin Phase 3 clinical trials, which Chereau said should start by the end of the year.

“The world has been talking about regenerative medicine for a long time, and there have been many ups and downs,” he said. “But now I think we are at the edge of seeing success popping up.”

Pervasis, founded in 2004, has raised $46 million in venture capital from investors including Flagship Ventures and Polaris Venture Partners. After receiving final FDA approval for the product, hopefully in 2012, Pervasis intends to partner with a major biotech or pharmaceutical company to bring the product to market, Chereau said.

At Organogenesis, the next product in the pipeline is a therapy for the regeneration of oral soft tissue. The product, known as CelTx, finished Phase 3 testing last year and is awaiting FDA approval. The company hopes to get the top 40 or 50 leading clinicians in the U.S. to adopt the product first, before seeking broader adoption, MacKay said.

Other therapies that fall within the category of regenerative medicine are not as close to commercialization. Therapies using stem cells to repair nerve or cardiac damage are heavily researched and in high demand, but they’re also far from ready, said George Annas, chair of the Department of Health Law, Bioethics and Human Rights at Boston University.

“This is a very important research area, and has a lot of promise,” Annas said. “But it’s a long ways away — at least a decade I would guess.”

Still, many signs are positive for the field overall. Regenerative medicine companies crossed the threshold of $1 billion in total revenue in 2008, Buckler said, and there are a large number of cell-based therapies in Phase 2 or Phase 3 trials currently. “There’s a great misconception that all of this is still in the research phase,” he said.

This new generation of therapeutics, Buckler added, “has the potential to change medicine ­— it has the potential to be curative” for many devastating diseases. “That’s the promise here that we have to live up to yet.” 


Regenerative Medicine Companies

Organogenesis Inc.

Location: Canton

CEO: Geoff MacKay

Technology: Cell-based products used in bio-active wound healing and bio-surgery.

Website: http://www.organogenesis.com

Founded: 1985

Advanced BioHealing Inc.

Location: Westport, Conn.

CEO: Kevin Rakin

Technology: Living cell therapies that repair damaged human tissue and enable the body to heal itself.

Website: http://abh.com/

Founded: 2003

Pervasis Therapeutics Inc.

Location: Cambridge

CEO: Fred Chereau

Technology: Biologically active therapeutics targeting vascular conditions

Website: http://www.pervasistx.com

Founded: 2003

Advanced Cell Technology Inc.

Location: Marlborough

CEO: William Caldwell

Technology: Cellular therapies for the treatment of rare and common diseases

Website: http://www.advancedcell.com/

Founded: 1994

Genzyme Corp.

Location: Cambridge

CEO: Henri A. Termeer

Technology: Pharmaceuticals and bio-surgical treatments

Website: http://www.genzyme.com/

Founded: 1981

 

SOURCE

Related Articles Read More >

Engineer inspecting artificial hip joint parts in quality control department in orthopaedic factory
Deburring and finishing for beautiful, functional medical devices
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I
Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech