Biological Dynamics
- Industry
- Biotechnology
- Founded Year
- 2008
- Headquarters
- San Diego, CA, USA
- Employee Count
- 134
Key People
- Paul R. Billings - CEO and Director
- Mike Aicher - Chief Operating Officer
- Michael Nall - Chief Commercial Officer
- Michael Russell - Director
Assessment
- Team
-
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises seasoned executives with extensive experience in medical technology and diagnostics.
Paul R. Billings has over 40 years of experience in genomics and molecular medicine. Mike Aicher co-founded the National Genetics Institute and led business units generating over $1 billion in annual revenue. Michael Nall has experience transitioning companies from R&D to full commercialization. Michael Russell brings financial oversight from his roles in emerging companies.
- Clinical Need
-
Aspect: Very Strong
Summary: Early detection of pancreatic cancer addresses a critical unmet need in oncology.
Pancreatic cancer has a low five-year survival rate of 12.5%, primarily due to late-stage detection. Early detection can improve survival rates to 44%. Biological Dynamics' ExoVita Pancreas assay aims to detect early-stage pancreatic ductal adenocarcinoma, potentially improving patient outcomes.
- Competition
-
Aspect: Somewhat crowded
Summary: The exosome diagnostics market has multiple players, but unique technology offers differentiation.
Competitors in the exosome diagnostics space include nRichDx, ArunA Bio, and ReNeuron. However, Biological Dynamics' proprietary ExoVerita platform offers a novel, fast, and cost-effective method for isolating nanoparticles, potentially setting it apart from competitors.
- Technical Challenge
-
Aspect: Predictable
Summary: The technology is advanced but operates within established scientific principles.
The ExoVerita platform utilizes AC Electrokinetics for exosome isolation, a method that, while innovative, is based on established scientific principles. This predictability reduces technical risk and facilitates regulatory approval processes.
- Patent
-
Aspect: Very Strong
Summary: The company holds robust patents protecting its proprietary technology.
Biological Dynamics' proprietary ExoVerita platform is protected by robust patents, safeguarding its unique exosome isolation technology. This strong intellectual property position provides a competitive advantage and potential for licensing opportunities.
- Financing
-
Aspect: Medium
Summary: The company has secured significant funding but faces financial challenges.
Biological Dynamics received $26.8M in venture funding in November 2015, with total funding reaching $43.8M. Despite this, the company ceased operations on June 30, 2024, due to financial challenges. A successor firm, involving several former employees, is continuing to advance the exosome platform developed by Biological Dynamics.
- Regulatory
-
Aspect: 510k/PMA
Summary: The company has achieved significant regulatory milestones.
In 2021, the U.S. Food and Drug Administration granted Breakthrough Device Designation for Biological Dynamics' liquid biopsy assay for early detection of pancreatic ductal adenocarcinoma. This designation facilitates expedited development and review, enhancing the company's regulatory standing.
Opportunity Rollup
- Odds of Success
- 4.25
- Peak Market Share
- 5.55
- Segment CAGR
- 47%
- Market Segment
- In Vitro Diagnostics
- Market Sub Segment
- Exosome Diagnostics
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.28 |
| 2 | 0.83 |
| 3 | 1.94 |
| 4 | 3.88 |
| 5 | 5.55 |
Key Takeaway
Biological Dynamics' innovative exosome-based diagnostics address a critical clinical need, but financial challenges and market competition pose significant risks.