Steven S. Brooks, M.D. M.B.A. F.A.C.C. 4 Deer Creek CourtReisterstown, MD 21136410-218-8400stevensbrooks87@gmail.com

Professional: SAGE GROWTH PARTNERS 2014-20153500 Boston Street, Suite 435, Baltimore, MD 21224

Chief Innovation Officer Healthcare Consultant Incubator Manager – Canton Health Ventures

FOOD AND DRUG ADMINISTRATION 2007-201410903 New Hampshire Avenue, WO 66-1552, Silver Spring, MD 20993

Medical Officer, Peripheral Vascular Device Branch, Office of Device Evaluation Entrepreneur-in-Residence team member 2012-2013- Goal of improving efficiencies

in FDA and reimbursement approval Center Science Council Subcommittee for Innovation FDA Medical Devices Reimbursement Task Force, Core Team member

MID-ATLANTIC CARDIOVASCULAR ASSOCIATES 2005-20071838 Greentree Rd., Ste 535, Baltimore, MD 21208

Private Practice General and Interventional Cardiology

UNIVERSITY OF MARYLAND MEDICAL CENTER 2003-2004Baltimore, MD Assistant Professor, Department of Medicine

Academic Faculty Interventional Cardiology

Industry ISOSIGHT Medical; Chief Operating Officer 2015-Present Positions Glysend; Advisory Board 2015-Present

Post-GraduateUNIVERSITY OF PITTSBURGH MEDICAL CENTER 2002-2003

Medical Pittsburgh, PA Interventional Cardiology Fellowship

Education UNIVERSITY OF PITTSBURGH MEDICAL CENTER 1999-2002Pittsburgh, PA Fellowship, Department of Cardiology

UNIVERSITY OF PITTSBURGH MEDICAL CENTER 1996-1999Pittsburgh, PA Residency, Department of Internal Medicine.

Education CAREY SCHOOL OF BUSINESS, JOHNS HOPKINS UNIVERSITY 2007-2011Baltimore, MD Degree: M.B.A. in Medical Service Management

CAREY SCHOOL OF BUSINESS, JOHNS HOPKINS UNIVERSITY 2008Baltimore, MD Business of Medicine Graduate Certificate

UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE 1991-1996Pittsburgh, PA Degree: M.D.

DUKE UNIVERSITY 1987-1991Durham, NC Degree: A.B. History

Consulting Lifetech Research, Baltimore, MD. 2007 Vascular Closure DeviceLadd Research Group, Cincinnati, OH 2005-2006 Cardiac Devices; Bifurcation stentingNelson Group, LLC, New York, NY, in re to Pfizer 2004 IMPACT:Important Multicultural Patient Awareness Communication & Training MeetingMillenium, Cambridge, MA 2004 Medical consulting and education.Guilford Pharmaceuticals, Baltimore, MD 2004 Medical consulting and education.Pfizer Pharmaceuticals Group, New York, NY 2004

Medical consulting and education.Symphony Capital, New York, NY. 2003-2004 Device for ECG monitoring and analysis of site and extent of cardiac injuryMerck & Co., Inc, West Point, PA 2001-2004 Medical consulting and education.

Publications L. K. Pack, D. C. Buckley, J. L. Goode, S. S. Brooks, and L. M. Lim, FDA perspective on the need for revised performance goals for evaluating stenting of femoropopliteal arteries: FDA Perspective on Revised Performance Goals, Catheter. Cardiovasc. Interv., 2013 Oct 6. doi: 10.1002/ccd.25221.

Ansari F, Pack LK, Brooks SS, Morrison TM, Design considerations for studies of the biomechanical environment of the femoropopliteal arteries. J Vasc Surg. 2013 Sep;58(3):804-13. doi: 10.1016/j.jvs.2013.03.052. Epub 2013 Jul 17.

Kumar A, Brooks SS, Cavanaugh K, Zuckerman B, FDA Perspective on objective performance goals and clinical trial Design for evaluating catheter-based treatment of critical limb ischemia. Journal of Vascular Surgery 2009 Dec;50(6):1474-6. Epub 2009 Nov 7.

Hsiao-Huei Chen, Catherine J. Baty, Tomoji Maeda, Steven Brooks, Linda C. Baker, Takahisa Ueyama,Erdal Gursoy, Samir Saba, Guy Salama, Barry London and Alexandre F.R. Stewart, Transcription Enhancer Factor-1-Related Factor-Transgenic Mice Develop Cardiac Conduction Defects Associated With Altered Connexin Phosphorylation, Circulation. 2004;110:2980-2987.

Combes A, Frye CS, Lemster BH, Brooks SS, Watkins SC, Feldman AM, McTiernan CF. Chronic exposure to interleukin 1beta induces a delayed and reversible alteration in excitation-contraction coupling of cultured cardiomyocytes. Pflugers Arch. 2002 Nov;445(2):246-56. Epub 2002 Sep 13.

Charles F. McTiernan, Bonnie Lemster, Carole Frye, Steven Brooks, Alain Combes, Arthur M. Feldman, Interleukin-1 Inhibits Phospholamban Gene Expression in Cultured Cardiomyocytes, Circulation Research. October 4, 1997, Vol 81/4:493-503.

Abstracts Alexandre F. Stewart, Tomoji Maeda, Samir Saba, Steven S. Brooks, Guy Salama. Hypophosphorylation of Connexin40 Mediates Conduction Disease in RTEF-1 Transgenic Mice., Supplement to Circulation October 23, 2001, Vol 104/17.

Steven S. Brooks, Henry Chong, C.William Balke, W.J. Lederer, Terry Rogers, Distinct Physiological “Fingerprint” Observed in Two Models of Cardiac Hypertrophy, Supplement to Circulation, October 15, 1995, Vol 92/8.

M.C.Alliegro, M.A.Alliegro, S.Brooks, B.Glaser, Amiloride Inhibition of Neovascularization, in vitro. Investigative Ophthalmology and Visual Science. Mar 15, 1991, Vol 32/4.

Presentations The FDA as a Partner; Jerusalem Business Networking Forum May 2015Aligning Value Proposition With Regulatory & Reimbursement Approach; Sarnoff Annual Mtg May 2015Integrated Regulatory & Reimbursement Strategy for US Market Entry; JHU Coulter Boot Camp Mar 2015First In Man Feasibility Studies; ICI Conference, Tel Aviv Dec 2014Academic Medical Centers and the Affordable Care Act; Sarnoff Annual Meeting May 2014

Webinar: From Discovery to Market, Sarnoff Cardiovascular Research Foundation; Jan 2012Webinar: Careers in Industry & Government, Sarnoff Cardiovascular Research Foundation; Nov 2010

L. Ricci, L. Braddock, S Brooks, E Russek-Cohen, “An FDA Perspective on ECG Algorithms” April 2010 presented at International Society of Computerized Electrocardiology (ISCE)

Alain Combes, Charles F. McTiernan, Steven S. Brooks, Arthur M. Feldman, Differential Effects of Pro-Inflammatory Cytokines on Myocardial Excitation-Contraction Coupling. Presented at Heart Failure Society Annual Convention: Baltimore, October 1997.

Research ENDEAVOR IV Trial: “A Randomized, Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Protocols Eluting Coronary Stent System Versus the TaxusTM Paclitaxel-Eluting Coronary Stent System in

De Novo Native Coronary Artery Lesions” Co-investigator.

COSTAR II: “ CObalt chromium STent with Antiproliferative for Restenosis II Trial” Co-investigator.

STRADIVARIUS - “Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant – The Intravascular Ultrasound Study” Co-investigator.

Research ASPECT Research Project 2008-2014 Experience Mathematical modeling of the Superficial Femoral Artery (SFA) using stenting, CT, IVUS

Collaboration between FDA, Industry, Academia Goal to describe inherent forces of SFA, implications for stent fracture, restenosis, optimal stent design

and testing.

University of Pittsburgh Medical Center, Department of Cardiology 2001-2003 Laboratory of Dr. Lisa Villanueva Open chest dog model of acute MI, employing radioactive labeling of thrombus and myocardial contrast

echo to detect distal embolization during angioplasty and stenting with and without Percu-surge distal protection device.

University of Pittsburgh Medical Center, Department of Cardiology 1996-2001 Laboratory of Drs. Barry London and Guy Salama studied effect of cytokines, including IL-1 and TNF, on contractility and calcium transients in cultured

neonatal rat cardiomyocytes utilized field stimulation of cultured myocytes, video edge detection techniques and Fura-2 Ca2+ dye

Sarnoff Fellowship: University of Maryland School of Medicine 1994-1995 Laboratory of Dr. C. William Balke, Dr. John W. Lederer, Dr. Terry B. Rogers compared physiologic response of cultured hypertrophic myocytes stimulated with phenylephrine vs. TPA to assess differences in contractility and calcium transients utilized field stimulation of cultured myocytes, video edge detection techniques and Fluo-3 Ca2+ dye poster presented at Nov. 1995 American Heart Association meeting

Awards FDA: Special Recognition Award 2010 For saving patient lives through prevention of stent implantation errors

FDA: Special Recognition Award 2010 For sustained superior performance in the regulation of complex combination products, including drug-eluting stents, and drug-coated balloons

FDA: Leveraging Collaboration Award 2010 For exceptional collaboration with academic and industry resources in

developing a successful paradigm for evaluating treatment options for acute descending thoracic aortic dissections

FDA: FDA Group Recognition 2010 For exemplary intra-center response to a serious public health concern

identified through signal detection and resolved through network collaborationStanley J. Sarnoff Society of Fellows 1994-1995

National research society one year fellowship award Dunloggin Medical Scholarship 1991-1995

Invited Johns Hopkins University Carey School of Business 2011-Present Faculty • Lecturer-“Drug & Device Regulation,” Discovery to Market Class

Johns Hopkins University Center For BioEngineering Innovation & Design (CBID) 2014-Present• Lecturer• Faculty Team Mentor

JHUTAMID; Advisor 2015-PresentPARC: Peripheral Academic Research Consortium 2012-2014

• Task Force memberCDISC: Standardized Data Collection for Cardiovascular Trials Initiative 2010-2011

• Task Force member and CoordinatorCardiovascular Research Technologies (CRT) 2009, 2011 2009, 2011

• Faculty and PanelistVascular InterVentional Advances (VIVA) 2011, 2012, 2014 2011-2012

• Faculty and PanelistTranscatheter Cardiovascular Therapeutics (TCT) 2009, 2012 2011-2012

• Faculty and Panelist

Certifications Medical Board Certifications: Interventional Cardiology, Cardiology, Internal Medicine 1996-2014Peripheral Vascular Angiography and InterventionLevel 2 EchocardiographyNuclear Licensure

Licensure State of Maryland Medical Licensure

Professional TEDCO MII Reviewer 2014-PresentAssociations TEDCO Maryland Entrepreneurs Resource List (MERL) Mentor 2014-Present

CMTP Green Park Collaborative: Center for Medical Technology Policy 2013-2014

• Advisory Committee MemberCMTP Coverage w/Evidence Development in the Management of Carotid Artery Stenosis 2013-2014

FDA Representative, Panel MemberAmerican College of Cardiology, FellowStanley J. Sarnoff Society of Fellows 1994-Present

Board of Directors 2014-2015Alumni Committee 2011-PresentChairman Alumni Committee 2014-2015

Maryland Israel Development Center 2010-PresentHead, Lifescience Committee 2012-Present

Journal of Electrocardiology, Reviewer 2012-2013