LynchBiologics.com | About LBIO
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About LBIO

Lynch Biologics, LLC (“LBIO” or “the Company”) is a biotechnology company whose mission is to develop safe and effective therapies to promote wound healing.  Its primary focus is treatment of DFUs.  Other indications of interest include post amputation wounds (possible Orphan Drug), venous stasis ulcers, pressure ulcers (bed sores), surgical wounds, including plastic surgery wounds and other complex or poorly healing wounds, e.g. major trauma and burns. The CEO and Chairman of LBIO, Dr. Sam Lynch, has 25 years of experience in research and development centered on recombinant human platelet-derived growth factor (rhPDGF) in regenerative medicine. He founded and led his previous company, BioMimetic Therapeutics, Inc. (BMTI) successfully over a 12 year period from product concept, to pre-clinical development to large randomized controlled clinical trials to two FDA approved (both full PMAs) combination products based on rhPDGF-BB for healing of musculoskeletal tissues.

 

We propose to leverage the extensive therapeutic human use of rhPDGF-BB, including established recombinant expression systems, purification and analytical test methods, commercial lot release criteria, known stability profiles, non-clinical toxicology information, human dosing information and human case reports supporting our hypothesis for an improved treatment regimen to develop a less expensive, more user friendly, more patient compliant and more efficacious treatment to improve the healing of DFUs.

 

ABSOLVE is the first and only innovative wound dressing that combines the benefits of both collagen “advanced wound dressings” and “wound biologics”.  Specifically, ABSOLVE has the benefits of a collagen wound dressing and also delivers a new, highly purified, more potent version of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) to the DFU.   The feasibility data presented here demonstrate that this product is a significant innovation compared to the advanced wound dressings and biologics currently available to treat DFUs.

New bio-therapeutics regenerative medicine company focused on improving dermal wound healing

Proven leadership founded and was CEO of previous regenerative medicine company sold for up to $500 million ($310 M upfront)

Proven, previously FDA approved, technologies in related indication

Large market (> $6B) and unmet medical need in chronic wounds

ABSOLVE is the first and only innovative wound dressing that combines the benefits of both collagen “advanced wound dressings” and “wound biologics”.

To complement Dr. Lynch’s substantial experience, LBIO has assembled a team of well-recognized experts in all aspects of biomedical product development and commercialization including clinical development (specifically in wound care), toxicology and pharmacokinetics, GMP manufacturing, quality systems, and regulatory strategy. This team has all the experience and skills to be able to successfully navigate the product development and commercialization challenges that may arise. One notable example of the talent assembled is that one of the company’s clinical experts is an MD vascular surgeon who served as a Medical Officer and reviewer at FDA (CDER) and co-authored FDA’s guidance document on development of wound care products entitled “Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds – Developing Products for Treatment”.  This team meets weekly to discuss progress, tasks completed and results obtained, challenges, opportunities, timelines and next steps.

Dr. Lynch successfully used this same team approach at his previous company, gathering some of the best and most experienced talent from across the nation, to guide the successful development and commercialization of two drug-device combination products, GEM 21S® and Augment® Bone Graft, through CDER and CDRH.  This track record of two full PMA approvals of complex combination products regulated by both CDER and CDRH divisions at FDA is unique.  These two products have been used to treat bone, or bone-soft tissue, wounds in hundreds of thousands of patients worldwide.  Moreover both of these previous development and commercialization programs were based on the same protein as LBIO is currently developing, recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB), giving LBIO substantial insight and a dramatic head start on its development and commercialization efforts.

Leadership Team

Sam Lynch, DMD, DMSc
Founder, Chairman and CEO

  • Harvard Medical/Dental School
  • Daiichi Sankyo US subsidiary
  • BioMimetic Therapeutics [Nasdaq: BMTI]
    Founder & CEO
  • Led BMTI to PMA approvals,
    IPO & strategic sale

Leslie Wisner-Lynch, DDS, DMSc
SVP, Product Development

  • Harvard Medical/Dental School
  • BMTI co-founder and Director of Applied Research

Additional Advisory Team 
with expertise in protein therapeutics, GMP manufacturing, tox, clinical and regulatory development of drug device combinations.

Only a small number of wound-care products have been shown to accelerate DFU healing in prospective, randomized registration trials. These include becaplermin (Regranex®; Gel Smith and Nephew), a topical gel containing rhPDGF-BB, 2 living skin equivalents: a bilayered skin substitute (Apligraf; Organogenesis, Inc., Canton, MA) and a human fibroblast-derived dermal substitute (Dermagraft; Advanced BioHealing, Inc., LaJolla, CA) and vacuum-assisted wound closure (V.A.C.; KCI, San Antonio, TX). Other modalities that are available but include less rigorous trial data include collagen, platelet-rich plasma, silver products, hyperbaric oxygen and electrical stimulation. In a recently published meta-analysis of 35 randomized, controlled trials evaluating diabetic foot ulcer advanced therapies the following results were reported:

  • Platelet-rich plasma did not improve diabetic ulcer healing compared to good standard wound care.
  • Dermagraft® biological skin equivalent in pooled results from three studies showed non-significant improvement compared to standard care, with ulcer healing favoring dermagraft (35% versus 24%).
  • Apligraf® biological skin equivalent bi-layer has been reported to improve healing over good standard wound care (55% versus 34%, p=.001; 2 studies).
  • Regranex® recombinant platelet-derived growth factor showed improvement in the percentage of ulcers healed compared to placebo or good standard wound care (58% versus 37%, p=0.04; 7 studies).
  • A.C. ® negative pressure wound therapy (NPWT) improved healing more than good standard wound care (43% versus 29%, p>0.05; 1 study).
  • There was low or insufficient evidence for all studies related to enhanced time to ulcer healing.

While the above data demonstrate the clear need for a more predictable advanced therapy to treat DFUs, nevertheless current wound care products generate over $4 billion in annual sales.

Given the worldwide projection of over 400 million individuals with diabetes by 2030, a current prevalence of DFUs of about 6% there is a clear and urgent need for a more predictable advanced therapeutic to heal DFUs to successfully address this large and growing health care challenge.

Diabetes Staggering Stats