LeakGuard™

  • Patented use of FDA-approved biodegradable material 
  • Eliminates the need for a second surgery
  • Reduces operation-related complications
  • Potential to save millions of lives and billions of dollars
  • $4.5 Billion Total Addressable Market
  • CAGR 13%

Needed: A Better Solution For Colorectal Cancer

Worldwide, there are 1.9 million new colorectal cancer diagnoses each year with new diagnoses facing an alarming rise in earlier age groups.


Anastomotic Leaks

  • Colorectal leaks occur in countless rectal cancer operations with a mortality rate of 10- 50%
  • Anastomotic leaks increase the costs by $50,000 per patient
  • 20-60% of patients unfortunately have to undergo an irreversible colostomy


Temporary ostomies are the current standard of care:

  • 50% Complication Rate
  • $20,00++ Cost Per Patient
  • Require a costly and risky second operation to reverse it 

LeakGuard Solution

  • Patented biodegradable stent
  • Protects anastomosis during critical healing period 
  • Slowly degrades and passes without need for removal
  • Obviates the need for a colostomy bag or any reversal surgeries 

$4.5 Billion

LeakGuard’s TAM is $4.5Bn for 600,000 colectomies ($7,500 stent) performed in the United States each year

100% surgical success (in pigs)

LeakGuard was implanted into Yukatan pigs (same size colon as humans)

28 day survival experiment with endoscopy at:

-day 7 

-day 14 

-day 28

Endoscopic view of freshly-placed LeakGuard stent

Anastomosis purposely left open to create a leak

Day 7: Stent in good position, protecting site

Day 14: Fully healed colon (with stent completely dissolved)

Competitor Analysis

Competitor Analysis

MedTech Innovator 2023 cohort winner!!!

Use of Funds

$5M 'Bridge'

  • Clinical Study- First-in-Man
  • FDA Clearance for Use in Colon

SAVE LIVES & THE PLANET

LeakGuard™: Revolutionizing Surgery & Catalyzing a Carbon-Free Footprint in the Healthcare Industry

Currently the healthcare industry is staggering behind with environmental issues.

*Approximately 10 years ago the first electric vehicle “start-up” (Tesla) revolutionized the automobile industry.*

LeakGuard™ is the first and only surgical solution with ZERO CARBON FOOTPRINT and NO ECOLOGICAL WASTE using CLEAN TECHNOLOGY with a SUSTAINABLE SUPPLY CHAIN that’s scalable.

This breakthrough medical technology represents an inflection point for both modern medicine and the way the healthcare industry advances climate change.

LeakGuard™ has been successfully designed, developed, and tested from the ground up with the planet in mind.

*SafeGuard Surgical’s biodegradable technology will catalyze a green revolution in the healthcare industry. *

Save the planet along with millions of lives!

Summary

The Problem:

  • Colorectal cancer is a global epidemic
  • Surgical leaks continue to be one of the most common complications from colorectal surgery
  • Increased length of stay, cost, cancer recurrence, morbidity and mortality
  • Colorectal surgery complications especially prominent in 'underserved’ communities
  • There is no FDA-approved method to protect patients from surgical leaks

The Solution:

  • LeakGuardTM, a biodegradable stent, to act as a barrier against surgical leaks
  • Eliminates need for costly and complicated colostomy bags 
  • The ONLY single surgery solution that does not require removal or a second procedure
  • LeakGuard’sTM TAM is $4.5Bn with 600,000 colon cases a year and a 13% CAGR
  • LeakGuard’sTM scalable technology will be a paradigm shift for surgery with a sustainable solution that solves a costly problem

Competitive Advantage: 

  • Addresses health inequities
  • Saves lives (and money)
  • Eco-friendly biotechnology
  • Biodegradable therefore does not need to be removed
  • Scalable to other surgeries

SafeGuard’s biodegradable and scalable technology is not just a product- it is a platform

Click Here For A One Minute Video

founder introduction

Founder- Dr. Scott Kelley

Dr. Kelley is a surgical oncologist trained in the surgical treatment of gastrointestinal malignancies of esophagus, pancreatic, stomach, colon and rectal, and hepatobiliary malignancies. He attended Dartmouth College and Columbia Medical School, and then completed General Surgery residency at the University of Pennsylvania and Surgical Oncology Fellowship at the H. Lee Moffitt Cancer Center. Dr Kelley has developed several patents across a wide range of domains.

Co-Founder- Jill Kelley

Jill Kelley is the first Arab American female founder of a medical biotech company, SafeGuard Surgical. She is an advocate of purpose-driven technology that addresses healthcare inequities/inequalities across the globe.  As a proud Lebanese immigrant, she is a zealous advocate for women and minorities in STEM and is a proud inventor and developer of multiple patents that deliver innovative solutions to unmet clinical needs. In her formative years she was studying to be a doctor. She published medical research papers at the University of Pennsylvania where she met her husband (and cofounder) Dr. Scott Kelley. Jill is an advisor to many countries as well as multinational companies (from startup to publicly traded) and brings her vast experience and expertise to strategically and successfully launch SafeGuard Surgical.

Advisory Board

Richard Toren

Peter Zaffaroni

Richard Toren

Entrepeneur-in-residence at the University of Miami. co-inventor of the EpiPen and Holter Monitor. 

Eamon Hobbs

Peter Zaffaroni

Richard Toren

President & Chief Executive Officer at Synchromune. Previously he was a Visiting Scholar and Entrepreneur in Residence for the Translational Accelerator at Brigham and Women’s Hospital, Harvard Medical School.

Peter Zaffaroni

Peter Zaffaroni

Peter Zaffaroni

Peter Zaffaroni is an associate in the Palo Alto office of Wilson Sonsini Goodrich & Rosati, where he practices corporate and securities law.

Kevin Skinner

Peter Zaffaroni

Peter Zaffaroni

Accomplished preclinical and clinical director with over 20 years of experience in medical device development.

Justin Chickles

Shripal Meghani, MTI Mentor

Justin Chickles

Co-founder of Glycyx, previous CEO and co-founder of Mobile Sense where he led the development and design, clinical trial, and partnerships. He was also a commercial leader at Johnson & Johnson and a business development executive at Purdue Pharma. 

Vishal Verma

Shripal Meghani, MTI Mentor

Justin Chickles

Partner at the Edgewood Group., a family office based in Silicon Valley. He is a senior advisor to the Honorable Dick Gephardt and Honorable Secretary Michael Chertoff.

Deb Ramsdell

Shripal Meghani, MTI Mentor

Shripal Meghani, MTI Mentor

CEO and COO of Phoenicis. Deborah has previously held positions at Lotus Tissue Repair, Inc., CMS International, Inc., Phoenicis Therapeutics, Orphan Technologies, Valerion Therapeutics, and Alopexx Enterprises. Ramsdell has over 28 years of experience in the regulatory affairs and clinical operations field.

Shripal Meghani, MTI Mentor

Shripal Meghani, MTI Mentor

Shripal Meghani, MTI Mentor

Seasoned Sr. Director of Business Development for Johnson & Johnson, bringing extensive experience from roles including board member at Cleveland Clinic Ventures, Director of Business Development at Phillips Healthcare.

Richard Moscicki, MD

Richard Moscicki, MD

Richard Moscicki, MD

Dr. Moscicki held key roles in the pharmaceutical industry and regulatory agencies, including serving as chief medical officer at PhRMA from 2017 to mid-2022 and overseeing regulatory matters at Genzyme Corporation. He also contributed to FDA's Center for Drug Evaluation and Research, holding the position of Deputy Center Director for Science Operations.

Contact Us

Email

Dr. Scott Kelley 

DrScottKelley@DrScottKelley.com


Administrative Assistant

Phone

Dr. Scott Kelley

813-431-7702

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