Preventing Surgical Complications with Contact Barriers Erik Robinson, PhD, CEO “In September of 2004 former President Bill Clinton underwent open heart surgery. 6 months later part of his left lung collapsed due to excessive scarring and fluid build-up. A second invasive surgery was needed to remove the scar tissue to restore normal organ function. Surgical complications such as the one former President Clinton experienced are unfortunately a common occurrence after surgery. At Sintact Medical Systems we prevent surgical complications through the use of contact barriers. These contact barriers prevent internal scarring and related scarring defects from occurring. 1 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. SURGICAL SCARRING Healing on the skin differs from healing of the internal organs and this difference is magnified when a patient undergoes surgery. Because of the compartmentalized nature of the internal organs it is exceedingly difficult for these surfaces to heal properly after they are damaged. This injury leads to internal scar formation or scar related defects. 2 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. http://www.cea1.com/ SURGICAL SCARRING Jin, J., et al., J of Surgical Research, 2009, 156(2), 297-304. Matthews, B.B., et al., J of Surgical Research 2005, 123(2), 227-234. These are images of surgical related scarring taken from patients during a repeat procedure to remove the scar tissue "Consensus in adhesion reduction management." The Obstetrician & Gynaecologist 6(S2): 1-16. (2004). 3 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. The patient suffers from a great deal of pain and discomfort but the surgeon also has a difficulty in removing these structures without causing more damage resulting in scar re-formation SURGICAL SCARRING RISK 60-90% 70-90% 4 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. 30-60% 50-90% The likelihood of someone developing a scarring event or scar related defect depend on what type of surgery you are having and what body cavity is involved. Whether in the chest cavity (cardiac), abdominal cavity, pelvic cavity, and various neurological procedures; the patient is at a seemingly constant risk of developing a scarring event or defect MARKET OPPORTUNITY CLINICAL IMPACT $300M $3-4B % 5.6 Revenue Expenditures CAGR Current products sales of antiadhesion products in the U.S. 15% Market Penetration Projected growth over the next few years within this market Market penetration of current products, this underpenetrated market is due to the poor efficacy (~50%) of available products which rely on resorbable or biodegradable formulations 5 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. 500K Estimated cost of repeat procedures, hospital readmissions, extended stays Repeat Surgeries Number of repeat surgeries to remove scar tissue annually SINTACT FILM™ At Sintact Medical we’ve developed a nondegradable surgical film to prevent the incidence of surgical scar formation. The non-degradable nature of the film lends to assuring scar formation cannot occur or re-form over extended periods of time. What we’ve been able to do is re-purpose an existing biocompatible material, one which is already used in current medical devices. There are tens of thousands of patients who currently have this same polymer somewhere in their body. This aspect lends to the safety and utilizing this material in this fashion due to its inclusion in other FDA approved devices. 6 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. PROJECTED MILESTONES A non-provisional patent was submitted to the USPTO office in 2014, through Northwestern University. Q2 2013 Prov. Patent Q3 2015 Q4 2018 Regulatory Approval Q4 2019 Abdominal Application Q2 2019 Terms of a license agreement have been reached and are awaiting further administrative and legal approval. 7 Non-Prov. Q2 Patent 2014 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. Post Market Surveillance Abdominal Patients Exit Post Approval Q2 2020 Exit Post Market Surveillance Our current path leads us to gaining regulatory approval and further develop the Sintact Film. Do to the simplicity of the product and large unmet need we do envision several exit opportunities upon completion of several value creating milestones. TEAM IN PLACE – FUNDING Funding Raised To Date • $325,000 in dilutive & non-dilutive funding • NSF SBIR $150,000 grant awarded June 2015 Gali Baler, PhD Erik Robinson, PhD COO Co-Founder CEO Co-Founder Co-Inventor Advisors David Wiseman, PhD Jim Kelly, MD, MBA, FACS Owner, Synechion, Inc. Leading Surgical Adhesion Expert Former Cardio Thoracic Surgeon Founded Medical Investment & Strategy Firm Dean Ho, PhD, BME Principal Investigator and Professor UCLA School of Dentistry 8 Jim Whittle, MBA General Business Counsel Medical Device Market Experience Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. Expected Financing Required • $750,000 for 24 months of operation to finalize, submit, and gain regulatory approval of a 510(k) clearance • Further financing to perform pilot clinical trials and gain initial traction/sales $4.2M FUNDING REQUIRED TO ACQUISITION $750k 9 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved. $4M Preventing Surgical Complications with Contact Barriers There is an obvious gap in the field of preventing scar formation following surgery. Sintact Medical bridges this gap in providing surgeons a means of reducing scar related complications keeping the patients out of the hospital We are Sintact Medical Systems and we are preventing surgical complications. Erik Robinson, PhD, CEO Sintactmed.com | erik@sintactmed.com | 312.493.3140 10 Presentation to Joe Smith © Sintact Medical Systems, Inc. All Rights Reserved.