Harbor MedTech Company Profile

Background

Overview

Harbor MedTech, Inc. is a fully integrated, commercial-stage regenerative medicine company specializing in advanced orthopedic soft tissue repair solutions. The company leverages its patented BriDGE® technology to transform Type-1 collagen into a bio-friendly, stabilized collagen matrix, thereby accelerating wound healing, supporting tissue regeneration, and limiting scar tissue and infectious biofilm formation.

Mission and Vision

Harbor MedTech's mission is to deliver innovative regenerative medicine solutions that enhance patient outcomes through advanced tissue repair technologies. The company's vision is to be a leader in regenerative medicine, providing effective and accessible treatments for a wide range of soft tissue injuries and chronic wounds.

Primary Area of Focus

The company's primary focus is on developing and commercializing tissue regeneration products for chronic wounds, hernia and joint repair, and other surgical applications. By utilizing its proprietary BriDGE® technology, Harbor MedTech aims to address the challenges associated with soft tissue injuries and chronic wounds, offering solutions that promote faster healing and improved tissue regeneration.

Industry Significance

In the regenerative medicine industry, Harbor MedTech stands out for its innovative approach to soft tissue repair. The company's products, such as the Architect® collagen matrix, have received FDA clearance and CE marking, indicating their safety and efficacy in treating complex skin wounds. This regulatory recognition underscores Harbor MedTech's commitment to advancing regenerative medicine and improving patient care.

Key Strategic Focus

Core Objectives

Harbor MedTech's strategic objectives include:

• Product Development: Expanding its product pipeline to address a broader range of soft tissue injuries and chronic wounds.

• Market Expansion: Increasing market penetration in both domestic and international markets through strategic partnerships and collaborations.

• Regulatory Approvals: Achieving additional regulatory clearances and approvals to enhance product accessibility and adoption.

Specific Areas of Specialization

The company specializes in:

• Orthobiologic Soft Tissue Injuries: Developing solutions for sports medicine applications, including treatments for Achilles tendon and rotator cuff injuries.

• General Surgical Repair: Providing products for hernia repair, breast reconstruction, and other surgical procedures.

• Chronic Skin Wounds: Offering treatments for difficult-to-heal wounds, such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers.

Key Technologies Utilized

Harbor MedTech's key technology is its proprietary BriDGE® collagen processing technology, which:

• Transforms Type-1 collagen into a stabilized collagen matrix.

• Accelerates wound healing.

• Supports tissue regeneration.

• Limits scar tissue formation.

• Prevents infectious biofilm formation.

Primary Markets or Conditions Targeted

The company targets markets and conditions including:

• Orthopedic Soft Tissue Injuries: Addressing sports-related injuries and general orthopedic repairs.

• Surgical Repairs: Providing solutions for hernia repair, breast reconstruction, and other surgical applications.

• Chronic Skin Wounds: Offering treatments for chronic wounds that are difficult to heal, such as diabetic foot ulcers and pressure ulcers.

Financials and Funding

Funding History

Harbor MedTech has raised a total of approximately $20 million over multiple funding rounds:

• Series A (June 2013): $2.5 million.

• Series B (October 2016): $7.5 million.

• Series C (September 2017): Amount undisclosed.

Recent Funding Rounds

In September 2017, Harbor MedTech completed a Series C funding round, raising an undisclosed amount. The company had previously raised $7.5 million in a Series B round in October 2016.

Notable Investors

Investors in Harbor MedTech include:

• Alumni Ventures

• MedTech Innovator

• Bascom Ventures

• Arsenal Capital Management

• Total Access Fund

Intended Utilization of Capital

The funds raised are intended to support:

• Product Development: Advancing the company's product pipeline, including the development of new applications for the BriDGE® technology.

• Regulatory Approvals: Securing additional FDA clearances and CE markings for new products.

• Market Expansion: Enhancing marketing efforts and expanding distribution channels to reach a broader patient population.

Pipeline Development

Key Pipeline Candidates

Harbor MedTech's pipeline includes:

• BPMatrix®: A pure, intact biologic product designed to stimulate tissue regeneration and prevent infection in orthopedic and general surgical repairs.

• PROcuff™ Bioimplant: BPMatrix mounted on patented woven sutures for arthroscopic rotator cuff repair, aiming to accelerate healing.

• Architect®: The first FDA-approved stabilized collagen matrix for chronic skin wounds, offering a "One and Done®" solution.

Stages of Clinical Trials or Product Development

The company has achieved FDA clearance and CE marking for its products, indicating successful completion of necessary clinical trials and regulatory processes.

Target Conditions

The pipeline targets conditions such as:

• Orthobiologic Soft Tissue Injuries: Including Achilles tendon and rotator cuff injuries.

• General Surgical Repairs: Such as hernia repair and breast reconstruction.

• Chronic Skin Wounds: Including diabetic foot ulcers, venous leg ulcers, and pressure ulcers.

Relevant Timelines for Anticipated Milestones

While specific timelines for upcoming milestones are not publicly disclosed, Harbor MedTech continues to advance its product development and regulatory approval processes to expand its market presence.

Technological Platform and Innovation

Proprietary Technologies

Harbor MedTech's proprietary BriDGE® technology is central to its product offerings. This technology transforms Type-1 collagen into a stabilized collagen matrix, enhancing tissue regeneration and healing.

Significant Scientific Methods

The company employs advanced collagen processing techniques to create bio-friendly, stabilized matrices that support the body's natural healing processes. These methods aim to accelerate wound healing, promote tissue regeneration, and prevent complications such as infection and scarring.

Leadership Team

Key Executive Profiles

• Jerome Mezger: Co-Founder, Chief Executive Officer, President & Chairman. Mr. Mezger has extensive experience in the medical device industry and has been instrumental in leading Harbor MedTech's strategic direction and growth.

• Keith Myers: Co-Founder, Chief Technology Officer & Vice President of Research & Development. Mr. Myers brings a strong background in biomedical engineering and has been pivotal in developing the company's proprietary technologies.

• Steve Priolo: Director of Quality Assurance & Regulatory Affairs. Mr. Priolo oversees the company's quality assurance and regulatory compliance, ensuring that products meet all necessary standards and regulations.

Leadership Changes

As of the latest available information, there have been no significant recent changes or appointments within Harbor MedTech's leadership team.

Competitor Profile

Market Insights and Dynamics

The regenerative medicine market, particularly in the area of soft tissue repair, is experiencing significant growth. Advancements in technology and an increasing focus on minimally invasive procedures are driving demand for innovative solutions like those offered by Harbor MedTech.

Competitor Analysis

Key competitors in the regenerative medicine space include:

• NOVADIP: A venture capital-backed company based in Mont-Saint-Guibert, Belgium, focusing on regenerative medicine solutions.

• Serigen: A venture capital-backed company located in Pune.