Dila-Pro The World’s First Smart Cervical Dilator Benjamin Lee, CEO Anne Kwei, CTO Matthew Lee, CMO/CRO Grace Shih, CFO

1. Dila-Pro The World’s First Smart Cervical Dilator Benjamin Lee, CEO Anne Kwei, CTO Matthew Lee, CMO/CRO Grace Shih, CFO Clark T. Hung, Ph.D. Rachel Masch, M.D., M.P.H.

2. The Problem 500,000 manual cervical dilation procedures annually in the US Current Dilators Lacks Patient-Tailored Specifications No Established Protocols Uncontrollable Dilation Rate Insufficient Dilation Inadvertent Induction of Labor Extreme Patient Discomfort Tissue Damage

3. The Solution Dila-Pro The World’s First Smart Cervical Dilator -portable and discreet -safe and efficient -patient tailored

4. Initial Prototype Design

5. Current Prototype • Rigid Air Tube: • Easy insertion • Air feed • Infrared emitter anchor Infrared sensor Infrared emitter Diameter Measurement System

6. Prototype Testing Pump Control Pressure sensor Infrared emitter/ sensor leads Ni-DAQ

7. Prototype Testing Electrical Lead to Computer Manual Air Supply Air Lead to Pressure Gauge

8. Prototype Demonstration

9. Hardware Refinement Small Peristaltic Pump • Pumps set volume of air into the balloon per turn • Vary RPM to vary rate of dilation • Proximity Sensor • Single, small unit • Ease of product preparation

10. Algorithm Details External Pressure > Threshold Diameter< Desired Dilation Rate a Input: Desired Diameter Base Rate: 0.5 cm/hr Diameter= Desired • Continuous Monitoring of: • Pressure • Diameter • Dilation Rate Stop Pump Signal Completion • Outputs/Display: • % Completion • Approximate amount of time remaining External Pressure < Threshold Diameter< Desired Dilation Rate a

11. Threshold Determination • Procedure: Stretch 10% at 0.05 mm/s = 3 mm/min • Maximum peak stress ≈ 100 kPa • Expectation for cervix dilation: <100 kPa stress due to slower dilation rate and known tissue relaxation due to force applied on cervix Myers, K. M.; Paskaleva, A. P.; House, M.; Socrate, S., Mechanical and biochemical properties of human cervical tissue. Acta Biomater 2008, 4 (1), 104-16.

12. Prototype Testing • Obtain Bovine Calf Cervices • Similar size and shape to human system • Tension test • Test Balloon System • Readouts: calculated parameters vs. real parameters • Anticipated Difficulties • Incorporating low-voltage electronics into the cervix • Should be safe given proper seal • Alternative mechanical ways of sensing diameter • Bursting the balloon • Operating well below the burst pressure of the balloon • Two-way pump allows us to deflate the balloon if needed

13. Summary • Substantial need and market for new cervical dilator • Advanced and innovative design • Efficient, patient-tailored dilation • Protection of cervical integrity • Prototype progress reflects design feasibility and device potential

14. Semester Timeline April 29 April 16 Poster presentation and prototype demonstration Bovine cervix testing April 2 April 23 Completion of workable prototype and data analysis Prototype design, calibration, and program finalization

15. Acknowledgements Dr. Clark Hung Professor of Biomedical Engineering Dr. Gordana Vunjak-Novakovic Professor of Biomedical Engineering Dr. Elizabeth Hillman Assistant Professor of Biomedical Engineering Keith Yeager Senior Staff Associate, Laboratory Manager Dr. Aaron Kyle Lecturer Dr. Rachel Masch Associate Director of Family Planning, Beth Israel Hospital Dr. Rujin Ju Beth Israel Hospital Matthew Bouchard Graduate Student in Biomedical Engineering Sarindr Bhumiratana Graduate Student in Biomedical Engineering Lauren Grosberg Graduate Student in Biomedical Engineering

16. Cost-Effectiveness We expect each device to be used approximately 5 times per week (5 times/week) x (52 weeks/year) x 2 years = 520 device usages $2100 per unit/520 usages = $4.04/usage $4 + $40 (disposable components) = $44, the total cost per usage of Dila-Pro Comparable to the cost of current dilators

17. Business Model Phase 1 Phase 2 Phase 3 Phase 4 Phase 1 Launch Dila-Pro Market to physicians Establish relationships with clinics and hospitals Develop a final marketable version of Dila-Pro In Vivo Testing of Dila-Pro FDA Approval Application Improve and update Dila-Pro Maintain strong relationship with customers

18. Manufacturing Cost

19. Company Objectives • Our Advantages • No major competition • Among the first to address this problem • Access to first-rate equipment • Mentorship of expert advisors Our Mission To be the pioneers of the next-generation of cervical dilation technology Our Vision To design an innovative and cost-effective cervical dilator that uses advanced, smart technology with an emphasis on patient needs

20. Market 25%: ~$50 million cervical dilators $200 million cervical dilation market per year

21. Dila-Pro The World’s First Smart Cervical Dilator portable and discreet safe and efficient patient tailored

22. Future Plans Prototype Design and Testing: • Finalize design and calibration • Bovine cervical phantom testing 3) Combine measured pressure and dilation to create dynamic biofeedback • Maximize portability by integrating air pump and monitoring device

23. Manufacturing Cost Profit Per Year Per Unit = $7,200

24. Financial Outlook • ‘Trade-In’ for $500 • Devote funds to R&D and advertising • ~50% of the market and second product release by 2017 $2,100 $40

25. Technical Feasibility • Short Term • Design and Calibration • Balloon Integrity – determine burst pressure • Accurate measurement of pressure and dilation – repeated calibration schemes • Dynamic dilation – response to pressure and diameter thresholds • Cervical Phantom Design and Testing • Phantom simulates physiologic conditions • Quantitatively comparable pressure • Viscoelasticity • Balloon functions safely under pseudophysiologic conditions • Moisture, temperature • Long term • Animal Model Testing • Human Clinical Trials

26. Regulatory Approval • Classification: Part 884 Subpart E – Obstetrical and Gynecological Surgical Devices • Device Class: Class III • Previous synthetic and expandable cervical dilators have been labeled class III • Novelty of the device lends itself to a class III classification • Requirements for FDA Approval: Premarket Approval (PMA) • A scientific, regulatory document that demonstrates the safety and effectiveness of the class III device • Nonclinical Laboratory Studies - Device properties, phantom tests, animal models • Clinical Investigations - Safety, efficacy, and all other data obtained from human clinical trials • Due to the nature of our device (low risk and unlikely to pose unreasonable risk of illness or injury), we do not foresee any major obstacles to obtaining FDA approval for Dila-Pro

27. Algorithm Details • Programming • Input: desired dilation diameter • Baseline dilation rate: 5 mm/hr = 1 cm/2 hr • Actively calculate: diameter and pressure • If external pressure > threshold, slow down dilation • If external pressure < threshold, speed up dilation • If calculated diameter = desired diameter, hold dilation, signal completion • Display: % completion or approximate amount of time remaining • Arduino Computing System • Small, centralized system