Focal Medical Provides Business Update

Ness Bermingham, Ph.D. Khosla Ventures partner and Intellia Therapeutics founder, joins Board.

 Advance of IOP cisplatin for locally recurrent oral cavity cancer into formal development.

Cary, North Carolina, January 30, 2024 — Focal Medical, Inc., (“Focal”) a Khosla Ventures backed biopharmaceutical company developing a targeted therapeutic system to treat inoperable tumors and to deliver genomic medicines, today announced the following corporate and business update.

New Board Member
Nessan Bermingham, Ph.D., Operating Partner, Khosla Ventures and Founder, Intellia Therapeutics, joins Focal Medical’s Board of Directors as a Non-Executive Board Member.  Dr. Bermingham has a long and highly successful career in the biotech industry. He has had founding and operating roles with Intellia Therapeutics and Liberate Bio and serves on multiple biotechnology company boards.

Dr. Bermingham will be a critical component of the continued growth and development of Focal Medical particularly as we advance our platform technology into the targeted delivery of genomic medicines.

Expands pipeline.
Focal Medical has advanced its second targeted therapeutic product candidate, IOP cisplatin for locally recurrent oral cavity cancer, into formal pre-clinical development.  This follows our lead targeted therapeutic product candidate, IOP gemcitabine for pancreatic cancer, which received FDA clearance of its IND this month.  Focal Medical’s second product candidate addresses the large unmet medical need for the significant number of patients with oral cavity cancer who experience disease recurrence^[1] following first line treatment with surgery, radiation, or chemotherapy.  Patients with recurrent disease have few treatment options and a 30% 5-year survival rate^[2].

In collaboration with Virginia Tech’s Animal Cancer Care and Research Center, Focal Medical has evaluated its targeted therapeutic system’s ability to deliver chemotherapeutics directly to naturally occurring oral cavity cancers in companion canines.  Focal Medical has demonstrated that its targeted therapeutic system can deliver chemotherapy at high concentration directly and specifically to target tumor tissue with little to no systemic exposure. In addition, a single tumor targeted treatment for 60 minutes resulted in a significant reduction in tumor volume as measured by CT scan in the animal treated with our targeted therapeutic system just 21 days post treatment.  This study is ongoing and continues to enroll companion canines with oral cavity cancers.

Focal Medical believes the targeted delivery of cisplatin directly to oral cavity tumors has the potential to improve outcomes for patients with recurrent disease by shrinking tumors prior to other treatment.

About Focal Medical
Focal Medical, Inc. is a privately held, biopharmaceutical company developing novel therapeutic products based on its innovative and patent protected targeted therapeutic system. The Company’s lead product is a targeted therapeutic product delivering gemcitabine (an FDA approved chemotherapeutic) actively and directly to the pancreas by non-circulatory pathways to treat pancreatic cancer. Focal Medical is expanding its product focus into therapies for other solid tumors and genomic medicine products. Its products utilize its innovative energy-based targeted therapeutic system. Focal Medical’s patented iontophoresis delivery system enables the internal, site-specific delivery of therapeutics actively, directly, and selectively to the target organ using non-circulatory pathways. The technology thus addresses certain significant challenges and limitations of traditional systemic drug delivery including systemic toxicity and barriers to therapeutic effect. Please visit our website at: www.focalmedical.co.

Company contacts:
Michael Aldridge, CEO
(919) 651-4656
[email protected]

Tony Voiers, COO
(919) 917-7324
[email protected]

Investor Contact:
Burns McClellan
Lee Roth / Eric Ando
[email protected] / [email protected]

Media Contact:
Burns McClellan
Selina Husain / Robert Flamm, Ph.D.
[email protected] / [email protected]

^[1]https://www.cancer.org/cancer/types/oral-cavity-and-oropharyngeal-cancer/about/key-statistics.html, Carvalho et. al, Oral Oncology, 2003, Shetty et. al, Frontiers in Oral Health, 2021, Zittel et. al, Clinical Oral Investigations, 2021
^[2] Wang et. al, Chin J Cancer, 2013