BioBolt Medical — Safer Access for Minimally Invasive Surgery

The Company

A surgical device platform, built around safety.

Founded in Tucson, Arizona, BioBolt Medical develops tools that protect patients during the highest-risk moments of surgery. Needle and trocar insertion during minimally invasive procedures can cause unintended injuries to abdominal organs and vessels — a risk that rises with every millimeter of tissue between the surgeon and their target.

Our devices are designed to remove that uncertainty. We currently have two proprietary assets: BioPAD, an FDA-cleared device for controlled access that is ready for immediate commercialization, and the BioBolt Surgical Stapler, a next-generation fixation technology in development.

Headquarters: Tucson, Arizona
Stage: FDA 510(k) cleared · pre-revenue
Partners: TauTona Group · UACI · Flinn Foundation
Focus: Minimally invasive surgical access

The Team

Surgeons and builders who have done this before.

CEO · Co-Founder

Kellen Chen, PhD

Biomedical engineer with 7+ years studying and commercializing devices and therapeutics. Leads BioBolt's strategy, fundraising, and commercial execution.
CMO · Co-Founder

Geoffrey C. Gurtner, MD, FACS

Chair & Professor, Department of Surgery, University of Arizona College of Medicine – Tucson. Formerly the Johnson & Johnson Distinguished Professor at Stanford, Vice Chairman of Innovation, Executive Director of the Advanced Wound Center, and President of the Wound Healing Society.
COO

Susan Hale

15+ years as Director of Quality Systems for medical devices. Leads BioBolt's operations, quality systems, and regulatory compliance.

Our Assets

Two devices. One mission: safer surgery.

FDA 510(k) Cleared

Primary Asset

BioPAD — BioBolt Pneumoperitoneum Assist Device

A single-use device that lifts the abdominal wall to enable safe, controlled Veress needle and trocar insertion — turning a blind, high-risk step into a consistent, intuitive one.

FDA 510(k) cleared (K242536) — ready for immediate U.S. commercialization
Validated in a 30-patient clinical study vs. standard-of-care towel clamps: faster, safer, more consistent
Backed by surgeon endorsements from Duke, Stanford, Penn, and Memorial Sloan Kettering
Protected by two granted US patents (11,690,649 and 11,871,961) with international filings pending
Platform-ready — extensible to trocar insertion, abdominal adhesions, and flexible retractor applications

Regulatory: 510(k) cleared, Oct 2024
Clinical: 30 patients, NCT04392635
Form factor: Single-use, disposable

Secondary Asset · In Development

BioBolt Surgical Stapler

A next-generation fixation device designed to eliminate 30–60 minutes of manual suturing. Biologic mesh fixation in approximately five minutes, with equivalent pull-out strength.

Addresses the ~30% of abdominal surgeries at risk for hernia
Patented, pre-clinical validation underway
Not yet FDA cleared — development ongoing

Recognition & Validation

Proven by the institutions that matter.

October 15, 2024 · Silver Spring, MD

FDA 510(k) Clearance —
BioPAD (K242536)

The BioBolt Pneumoperitoneum Assist Device (BioPAD) received FDA 510(k) clearance on October 15, 2024, establishing substantial equivalence to a legally marketed predicate device. The clearance expands indications for use across all regions of the abdominal wall — including Palmer's Point and umbilical entry — for the establishment of pneumoperitoneum during laparoscopic procedures.

K242536 · Class II · Product Code HIF · Ready for Commercialization

510(k) Number: K242536 — cleared October 15, 2024
Regulation: 21 CFR 884.1730 — Laparoscopic Insufflator (Class II)
Indications for Use: Use with a Veress needle for establishment of a pneumoperitoneum during laparoscopic procedures
Issuing Office: FDA CDRH · Division of Reproductive, Gynecology, and Urology Devices

2023 – 2024 · USPTO

Two Granted U.S. Patents —
Protecting the BioPAD Platform

BioBolt's controlled-access platform is protected by two issued United States patents covering the core apparatus and methods — from the suction-based retractor architecture to the trocar positioning system. Inventors: Joseph Rimsa and Geoffrey C. Gurtner. International filings are pending.

2 Granted US Patents · International Filings Pending

US 11,690,649 B2: Retractor Apparatus and Methods for Use
Issued July 4, 2023. Covers a substrate with an array of suction assemblies that attaches to tissue via vacuum force, with an integrated positioning guide for instruments.
US 11,871,961 B2: Trocar Positioning Apparatus and Methods for Use
Issued January 16, 2024. Extends the platform to trocar positioning, using the same suction-based substrate to maintain a predetermined configuration under vacuum.

May 2023 · Tucson, AZ

University of Arizona Center for Innovation —
Sponsored Launch Winner

Selected from a competitive field of Arizona startups, BioBolt Medical won a sponsored year of admission into the UACI incubation program — a $15,000 package funded by R&A CPAs, including facilities, programming, mentorship, and lab space.

$15,000 Package · 12-Month Residency · 75+ Fellow Startups

Selection Panel: Doug Hockstad · James Hanna · Quan Nguyen · Phillip Dalrymple
Sponsor: R&A CPAs — Top 500 Firm Nationally
Key Benefit: Office & lab space, prototyping center, structured 27-point program roadmap
Current Status: Active UACI client since 2022

April 2024 · Phoenix, AZ

Flinn Foundation Bioscience Entrepreneurship Program

Selected as one of six Arizona bioscience startups for the 11th cohort of the Flinn Foundation's prestigious entrepreneurship program — chosen from 38 applicants statewide. The program provided $30,000 in non-dilutive funding via the Arizona Bioindustry Association (AZBio), a personalized learning plan, and a one-year seat on Arizona's Bioscience Roadmap Steering Committee.

Ongoing

TauTona Group — Medical Device Platform Partner

Company spun out primary products based on development from TauTona Group, a Redwood City-based idea incubator. The technology was initially developed there before being spun out as core technologies for BioBolt Medical.

Surgeons on BioPAD

What leading surgeons are saying.

BioPAD makes a common, high-risk step in surgery safer. It moves us closer to making access injuries a never event — and has real value for surgeons and patients alike.

Jacob A. Greenberg, MD

Chief, Division of Minimally Invasive Surgery
Duke Health
BioPAD helps obtain traction better than standard-of-care clamps with two people.

Monica M. Dua, MD

Clinical Professor, General Surgery
Stanford University School of Medicine
As a plastic surgeon managing complex abdominal wall cases, I see BioPAD as an elegant solution to the critical challenge of safe MIS access.

John P. Fischer, MD, MPH, FACS

Professor of Surgery, Plastic Surgery
University of Pennsylvania
Laparoscopically entering the abdomen with a Veress needle is nerve-wracking since you cannot know for sure what lies below.

Deshka Foster, MD, PhD

Dual Fellow, General Surgery & HPB
Memorial Sloan Kettering
Improves consistency and reduces the training burden for safe abdominal access.

Daniel J. Delitto, MD, PhD, FACS

Assistant Professor, General Surgery
Stanford University School of Medicine
Useful at Palmer's point and umbilical — potentially even more useful with higher-BMI patients.

Micaela Esquivel, MD

Clinical Associate Professor, General Surgery
Stanford University School of Medicine

Reimagining safety in robotic and minimally invasive surgery.

A surgical device platform, built around safety.

Surgeons and builders who have done this before.

Kellen Chen, PhD

Geoffrey C. Gurtner, MD, FACS

Susan Hale

Two devices. One mission: safer surgery.

BioPAD — BioBolt Pneumoperitoneum Assist Device

BioBolt Surgical Stapler

Proven by the institutions that matter.

FDA 510(k) Clearance —
BioPAD (K242536)

Two Granted U.S. Patents —
Protecting the BioPAD Platform

University of Arizona Center for Innovation —
Sponsored Launch Winner

Flinn Foundation Bioscience Entrepreneurship Program

TauTona Group — Medical Device Platform Partner

What leading surgeons are saying.

Interested in partnership, distribution, or investment?

Reimagining safety in robotic and minimally invasive surgery.

A surgical device platform, built around safety.

Surgeons and builders who have done this before.

Kellen Chen, PhD

Geoffrey C. Gurtner, MD, FACS

Susan Hale

Two devices. One mission: safer surgery.

BioPAD — BioBolt Pneumoperitoneum Assist Device

BioBolt Surgical Stapler

Proven by the institutions that matter.

FDA 510(k) Clearance — BioPAD (K242536)

Two Granted U.S. Patents — Protecting the BioPAD Platform

University of Arizona Center for Innovation — Sponsored Launch Winner

Flinn Foundation Bioscience Entrepreneurship Program

TauTona Group — Medical Device Platform Partner

What leading surgeons are saying.

Interested in partnership, distribution, or investment?

FDA 510(k) Clearance —
BioPAD (K242536)

Two Granted U.S. Patents —
Protecting the BioPAD Platform

University of Arizona Center for Innovation —
Sponsored Launch Winner