Seeing is Curing®

Company overview

 

Curadel Surgical Innovations, Inc. (CSI) is a privately held company headquartered in Natick Massachusetts, 16 miles due west of Boston. CSI has exclusive worldwide licensing rights from Curadel, LLC for the development, manufacture, marketing, and commercialization of Curadel’s extensive FLARE® portfolio of contrast agents (drugs) for image-guided surgery.

 

Our mission is to improve human surgery by visually enhancing anatomy of every kind. The technology we’ve developed, called FLARE®, uses low levels of invisible near-infrared (NIR) fluorescent light to highlight any structure in the body that could help the surgeon perform better surgery. Using FLARE®, blood vessels, nerve, tumors, ureters, lymph nodes, cartilage, and many others can now be “lit up” like a light bulb using NIR imaging systems available in most hospitals around the world. Learn more about FLARE® technology here or browse our drug pipeline here.

 

Making this possible, Curadel scientists have been awarded over $61M to date in grant funding to move FLARE® technology from bench to bedside. This includes a recent, prestigious $4M SBIR Phase 2B “Bridge” grant to bring contrast agent ZW800-1 to market approval for the intraoperative anatomical enhancement of ureters.

 

Our mission is to revolutionize surgery

Mission and values

 

 

Mission Statement

Our mission is to revolutionize surgery.

 

 

Mission

Our mission is to make surgery “personal.” For over 100 years, human surgery has relied on the eyes, brain, and experience of the surgeon to differentiate one tissue from another. However, every patient is different, and many tissues look alike to the human eye. Curadel’s FLARE® technology harnesses the penetration depth and high optical contrast of near-infrared fluorescent light to “highlight” up to three different tissues and tumors during surgery. By doing so, we enable surgeons to completely resect tissues and tumors that need to be resected while simultaneously avoiding tissues that need to be preserved. FLARE® personalizes surgery in a way no other technology can.

 

 

Personal Values = Business Values = Moral Compass

Integrity               Doing the right thing, even when not acknowledged by others or convenient for us.

Innovation           Fearless thinking and creative problem-solving.

Excellence            No compromising in the quality of all that we do.

Collaboration      Interactions with internal and external stakeholders that promote collaboration and a desire to continue working together.

Adaptability        Becoming profitable and sustaining profitability requires openness, flexibility, and a fast response to unexpected events.

 

 

Strategic Values = Practical Compass

Safe quality products    Adherence to the principles of a Quality Management System (QMS) and a desire for continual improvement.

Leader in the field          Always be one step ahead of the competition through innovation and perseverance.

Profitability                      Profit, and especially continually increasing profit, will enable us to innovate, remain leaders in the field, and weather unexpected storms.

Management Team

John V. Frangioni,
M.D., Ph.D.

CEO

John V. Frangioni

Dr. Frangioni is an internationally renowned expert in molecular imaging and image-guided surgery. At Curadel Surgical Innovations he leads a talented team dedicated to the market approval and post-market activities of FLARE® contrast agents under cGMP and an ICH Q10 and 21 CFR 210/211 compliant quality management system.

 

Since inventing FLARE® technology, his group has led the field of NIR fluorescence with over 210 peer-reviewed papers, 20,000 citations, an impact factor of 71.6, an h-index of 59, and over 800 patients studied in published clinical trials. Dr. Frangioni has been the Principal Investigator of 16 peer-reviewed research grants from the National Institutes of Health totaling over $61M. He was previously Professor of Medicine and Professor of Radiology at Harvard Medical School, and was board-certified in internal medicine and medical oncology. He is the recipient of Mentor of the Year at Harvard Medical School, the Edward M. Kennedy Award for Healthcare Innovation, a Visiting Professorship of the Royal Netherlands Academy of Arts and Sciences, and induction into the American Society for Clinical Investigation.

 

Dr. Frangioni received his undergraduate degree in Engineering Sciences from Harvard College, his  M.D. from Harvard Medical School and the Massachusetts Institute of Technology’s Health Science and Technology (HST) Program, and his Ph.D. in Cellular and Molecular Physiology from the Harvard Graduate School of Arts and Sciences.

Kris Piper, M.S.
Chief of Regulatory Affairs

Kris Piper

Mr. Piper has more than 40 years’ experience in new drug development in both big pharma and biotech with a highly successful track record in taking products from pre-IND to market approval and commercialization.  Over the course of his career, Kris has successfully submitted more than 35 INDs and gained approval of more than 20 NDAs and BLAs.  His experience includes development of Regulatory Strategy, Regulatory CMC, Quality Systems, Compliance, and Clinical Development strategies for companies with biopharmaceutical therapeutic and imaging products being developed and distributed in markets regulated by the US FDA, Canada, the European Commission, and other international regulatory agencies.

 

Kris holds a B.S. in Animal Science and a M.S. in Physiology from the University of California at Davis.

Brad Rosenblum, CPA
Chief Financial Officer

Brad Rosenblum

Mr. Rosenblum has a demonstrated record of building lean, scalable operations and managing cross-functional teams including operations, sales, and research groups to execute strategies and create value for stakeholders. As a Principal at BMR Financial Consulting, Mr. Rosenblum acts as a partner with CEO's and senior management teams to ensure that decisions made across the organization are financially prudent.

Mark W. Bordo, B.S.
Director of Science & Technology

Mark W. Bordo

Trained in both organic chemistry and computer science, Mr. Bordo is Director of Science and Technology at Curadel Surgical Innovations where he oversees drug substance manufacturing, drug product manufacturing, on-site auditing, and regulatory filings. Mr. Bordo is highly skilled in polymethine indocyanine chemistry and was instrumental in the development of the cGMP syntheses for FLARE® drugs.

Katherine T. Scott, Ph.D.

Director of Clinical Operations

Katherine T. Scott

Dr. Scott has more than 15 years of experience in clinical trial operations, providing strategic input and trial oversight at all stages of development. She has overall responsibility for the conduct of Curadel’s clinical studies, working closely with the entire operational study team.

 

Originally trained as a Medical Physicist, Kate specialized in oncologic applications of Magnetic Resonance Imaging (MRI) at the Royal Marsden Hospital in the UK, the University of Sydney, Australia, and the Institute for Biodiagnostics at the National Research Council of Canada. Subsequently, she held post-doctoral research positions at Harvard Medical School hospitals, before being recruited to the R&D division of Siemens Medical Solution. In this latter role, she was responsible for the implementation of the first Alzheimer’s Disease Neuroimaging Initiative (ADNI) study protocols on 36 MRI systems at 31 sites across the USA. The subsequent positive EMA qualification letter on the use of hippocampal volumes as an MRI biomarker, triggered a passion for clinical trial research, leading to positions at large (PAREXEL) and small (New England Research Institutes) Contract Research Organizations, as well as an Institutional Review Board Chair role for 5 years. Her research and clinical trials have encompassed areas as diverse as oncology, atherosclerosis, cartilage degeneration, stroke, arthritis, ophthalmology, sickle cell disease, dysphonia/dysphasia, and β-thalassemia.

 

Dr. Scott received her undergraduate degree in Physics from University of Leeds, UK, her Masters’ degree in Medical Physics from the University of Surrey, UK, and her Ph.D. in Cancer Medicine from the University of Sydney, Australia.

 

Tammy Gauthier, M.S.
Manager of Quality

Tammy Gauthier

Tammy Gauthier is the Quality Manager at Curadel Surgical Innovations where she oversees internal and external Quality Systems, Supplier Development, and New Product Development. With a Masters in Regulatory Science, and trained in the Association for the Advancement of Medical Instrumentation, Design Control and Industry Practices, she provides guidance to consistently and effectively monitor Curadel’s Quality Management System and projects to ensure the manufacture of high quality product, and facilitates compliance within regulatory landscapes and global requirements.

Board of directors

Garen Bohlin
Chairperson

Garen Bohlin

Mr. Bohlin spent close to 30 years in executive roles in the biopharmaceutical industry in positions of CFO, EVP, COO and CEO in four organizations. He was instrumental in the development and success of each of these companies and all four were sold to big pharma or larger biopharma organizations including Genetics Institute to American Home/Wyeth, Syntonix Pharmaceuticals to Biogen, Sirtris Pharmaceuticals to GlaxoSmithKline and Constellation Pharmaceuticals to MorphoSys.

 

In addition to CSI, he currently serves on the boards of two public companies: Collegium Pharmaceutical and Karyopharm Therapeutics. Previously, he has served on the boards of Acusphere, Praecis Pharmaceuticals, Precision Dermatology, Proteon Therapeutics, SpringLeaf Therapeutics, Targanta Therapeutics and Tetraphase Pharmaceuticals.

 

Before entering the biopharmaceutical industry, Mr. Bohlin received a B.S. degree from the University of Illinois with accounting and finance concentrations, and then spent over a decade at Arthur Andersen & Co. where he was a partner.

Walid Fakhry
Director

Walid Fakhry

Mr. Fakhry is a partner at ESO Capital LLP in London, a mid-market hybrid capital provider. ESO Capital has over $800M under management and specializes in funding small- and medium-sized enterprises across Europe.

Mr. Fakhry has a twenty five year track record in private equity, corporate finance, and entrepreneurship. In the mid-1990s, he created and sold one of the largest ISP’s in the Middle East.  By the late 1990s he joined JP Morgan’s Technology, Media, and Telecom (TMT) corporate finance group in London, working with a variety of clients on mergers, sales, debt and equity placements, and IPOs. For ESO Capital he runs overall operations and is responsible for TMT coverage.

 

Mr. Fakhry received his B.Sc. degree in Mechanical Engineering and Finance, and M.Sc. degree in Civil and Environmental Engineering from the Massachusetts Institute of Technology.

Marc B. Garnick, M.D.
Director

Marc B. Garnick, M.D.

Dr. Garnick is an internationally renowned expert in medical oncology and urologic cancer and the Gorman Brothers Professor of Medicine at Harvard Medical School. He has dedicated his career to the development of new therapies for urologic cancer, with an emphasis on prostate cancer.

 

Dr. Garnick was Vice President for Clinical Development at Genetics Institute prior to their $3B acquisition by Wyeth, and Chief Medical Officer at Praecis Pharmaceuticals prior to their acquisition by Glaxo-Smith-Kline.

In addition to his academic and business interests, Dr. Garnick serves as Director of Community Cancer Services for Network Development at BIDMC and is a special advisor to the FDA. His philanthropic efforts include Executive Director of Physician Initiated Philanthropy at BIDMC, Vice-Chair of the BIDMC Trustee Advisory Board, member of the University of Pennsylvania Medicine Board, and Trustee Emeritus of Bowdoin College.

Henry Kay, MS, MBA
Director

Henry Kay, MS, MBA

Henry Kay is an active angel investor and a member of Boston Harbor Angels and Sky Venture Group, both Angel investing groups in the Boston area. Mr. Kay retired from Boston Scientific in 2006, where he was Group Vice President of New Market Development/Strategic Planning, Endosurgery Boston Scientific Corporation (BSC). Prior to joining BSC, he was based in the UK for five years as Senior Vice President, Sales and Marketing for Allergan Europe, a global eye care company.

 

Mr. Kay has 40 years of experience in the medical industry in roles which include R&D, International Marketing, Regulatory Affairs, and Strategic Planning for major pharmaceutical companies, including Schering-Plough, American Home Products, Sterling Drug and Allergan.

 

Mr. Kay is a retired fellow of the Royal Society of Medicine (UK). He is invested in more than 15 companies, several of which are in Canada (e-Sight, Exact Imaging, Cellaegis, MyndTec), and has served on the boards of Cellaegis, MyndTec and Exact Imaging. He also served on the Boards of several start-up health care companies, including Smart Cells (sold to Merck in 2010), Cool Systems (also sold) and  Microfluidics, a public company in the equipment space for pharmaceutical manufacture (sold to IDEX in 2010).  Mr. Kay currently serves as a board member of Cristcot Medical, and Cannuflow and as board chair of Covina, a Halifax based startup in the medical device field. He works closely with the Canadian Consulate in Boston to mentor several Canadian startups including Salutech, a start up in the AFib space.   He is also an advisor to Quthero, a Toronto based company developing products for wound healing.

John V. Frangioni,
M.D., Ph.D.

CEO

John V. Frangioni, M.D., Ph.D.

Dr. Frangioni is an internationally renowned expert in molecular imaging and image-guided surgery. At Curadel Surgical Innovations he leads a talented team dedicated to the market approval and post-market activities of FLARE® contrast agents under cGMP and an ICH Q10 and 21 CFR 210/211 compliant quality management system.

 

Since inventing FLARE® technology, his group has led the field of NIR fluorescence with over 210 peer-reviewed papers, 20,000 citations, an impact factor of 71.6, an h-index of 59, and over 800 patients studied in published clinical trials. Dr. Frangioni has been the Principal Investigator of 16 peer-reviewed research grants from the National Institutes of Health totaling over $61M. He was previously Professor of Medicine and Professor of Radiology at Harvard Medical School, and was board-certified in internal medicine and medical oncology. He is the recipient of Mentor of the Year at Harvard Medical School, the Edward M. Kennedy Award for Healthcare Innovation, a Visiting Professorship of the Royal Netherlands Academy of Arts and Sciences, and induction into the American Society for Clinical Investigation.

 

Dr. Frangioni received his undergraduate degree in Engineering Sciences from Harvard College, his  M.D. from Harvard Medical School and the Massachusetts Institute of Technology’s Health Science and Technology (HST) Program, and his Ph.D. in Cellular and Molecular Physiology from the Harvard Graduate School of Arts and Sciences.

In the news

Date Event
October 2023 FDA grants nizaracianine triflutate (aka ZW800-1) Fast Track status
June 2020 Curadel is awarded a prestigious $4M SBIR Phase 2B “Bridge” grant to bring contrast agent ZW800-1 to market for intraoperative imaging of ureters. This brings cumulative grant funding for FLARE® technology to $61M
May 2020 Phase 1 and Phase 2 clinical trial results of cRGD-ZW800-1 for anatomical enhancement of colorectal cancer during surgery published in Clinical Cancer Research (PMID32345649)
April 2020 Curadel Surgical Innovations secures its Series A Preferred funding
July 2019 Phase 1 and Phase 2 clinical trial results of ZW800-1 for anatomical enhancement of the ureters during surgery published in Nature Communications (PMC6635391)

Overview

Anatomy books make surgery look easy, but it’s not.

 

Most tissues, organs, and tumors in the body blend into their surroundings or are obscured by overlying blood and tissue. Because of this, surgery is technically challenging and requires years of training and skill. When considering that there are over 300 million surgeries performed worldwide each year, with a staggering 17% overall complication rate, there’s certainly room for improvement.

 

Similarly, there are almost 30 million cancer surgeries performed worldwide each year, and on average, 12% result in positive margins, meaning tumor was left behind, often because its borders or “margins,” can’t be seen well enough by the surgeon.

 

NIR light between 700 nm and 900 nm exhibits low photon absorbance and scatter, and can thus penetrate several millimeters into living tissue, and through blood. Autofluorescence in the NIR spectrum is also low, so the use of a fluorophore that converts one NIR wavelength to another will generate extremely high visual contrast. By directing a NIR fluorophore, also called a contrast agent, to the desired anatomical structure, that structure can be visually enhanced and highlighted, with high sensitivity and specificity. Enhancement of normal or diseased anatomy, in turn, embellishes the surgeon’s training, experience, and judgment.

 

Curadel Surgical Innovations solves the visual contrast problem in human surgery using a technology platform called FLARE® (FLuorescence-Assisted Resection and Exploration). Our Anatomic Enhancer® brand of FLARE® contrast agents can light up almost every type of anatomy in the body, be it normal or diseased. In the images above and below, the lime green color denotes otherwise invisible NIR light from a FLARE® contrast agent.

 

Whether it’s a tumor that needs to be resected completely or a normal tissue/organ that needs to be avoided, FLARE® can do it all. View our publications to dive deeper into the technology. Curadel Surgical Innovations won’t stop until human surgery reaches a new level of performance, which in turn will benefit patients, surgeons, hospitals, insurers, and the healthcare system in general.

Publications

 

Since 2001, scientists of Curadel Surgical Innovations have led the field of anatomical enhancement of surgery using NIR fluorescent light. Their 200+ peer-reviewed publications have achieved an unparalleled record of impact in the field, with the following metrics as of October 2023:

 

  Total Citations:   26,052

  Impact Factor:   101.4

  h-Index:   67

 

Total Citations: The total number of times all papers have been cited in the scientific literature. In general, it reflects the importance of the body of work because citations mean that other scientists are using the papers as either a foundation or comparator for their own work. 

 

Impact Factor: The average number of times each individual paper has been cited in the scientific literature. An “excellent” impact factor is ≥ 15. Impact factors ≥ 30 are consistent with laureates [PMID: 24814674].

 

h-Index: The number of publications N that have been cited at least N times in the scientific literature. A measure of consistent achievement over long periods of time, as well as overall impact of a body of work. An h-index of ≈ 18 is consistent with Full Professorship. An h-index of ≥ 45 is consistent with induction into the National Academy of Sciences [PMID: 16275915].

 

The following subset of publications from Curadel Surgical Innovations scientists are peer-reviewed clinical trials in image-guided surgery and document the first 700+ patients studied using FLARE® technology:

ReferenceS

 

1.   Lee BT, Hutteman M, Gioux S, Stockdale A, Lin SJ, Ngo LH, Frangioni JV. The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in perforator flap breast reconstruction. Plast Reconstr Surg. 2010 Nov;126(5):1472–1481. PMCID: PMC2974179

2.   de Valk KS, Handgraaf HJ, Deken MM, Sibinga Mulder BG, Valentijn AR, Terwisscha van Scheltinga AG, Kuil J, van Esdonk MJ, Vuijk J, Bevers RF, Peeters KC, Holman FA, Frangioni JV, Burggraaf J, Vahrmeijer AL. A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery. Nat Commun. 2019 Jul 16;10(1):3118. PMCID: PMC6635391

3.   van der Vorst JR, Schaafsma BE, Hutteman M, Verbeek FPR, Liefers G-J, Hartgrink HH, Smit VTHBM, Lowik CWGM, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Near-infrared fluorescence-guided resection of colorectal liver metastases. Cancer. 2013 Sep 15;119(18):3411–3418. PMCID: PMC3775857

4.   Handgraaf HJM, Boogerd LSF, Hoppener DJ, Peloso A, Sibinga Mulder BG, Hoogstins CES, Hartgrink HH, van de Velde CJH, Mieog JSD, Swijnenburg RJ, Putter H, Maestri M, Braat AE, Frangioni JV, Vahrmeijer AL. Long-term follow-up after near-infrared fluorescence-guided resection of colorectal liver metastases: A retrospective multicenter analysis. Eur J Surg Oncol J Eur Soc Surg Oncol Br Assoc Surg Oncol. 2017 Aug;43(8):1463–1471. PMCID: PMC5534212

5.   Tummers QRJG, Verbeek FPR, Schaafsma BE, Boonstra MC, van der Vorst JR, Liefers G-J, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Real-time intraoperative detection of breast cancer using near-infrared fluorescence imaging and Methylene Blue. Eur J Surg Oncol J Eur Soc Surg Oncol Br Assoc Surg Oncol. 2014 Jul;40(7):850–858. PMCID: PMC4035701

6.   Tummers QRJG, Schepers A, Hamming JF, Kievit J, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Intraoperative guidance in parathyroid surgery using near-infrared fluorescence imaging and low-dose Methylene Blue. Surgery. 2015 Nov;158(5):1323–1330. PMCID: PMC4603995

7.   van der Vorst JR, Schaafsma BE, Verbeek FPR, Swijnenburg R-J, Tummers QRJG, Hutteman M, Hamming JF, Kievit J, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Intraoperative near-infrared fluorescence imaging of parathyroid adenomas with use of low-dose methylene blue. Head Neck. 2014 Jun;36(6):853–858. PMCID: PMC3779489

8.   Tummers QRJG, Verbeek FPR, Prevoo HAJM, Braat AE, Baeten CIM, Frangioni JV, van de Velde CJH, Vahrmeijer AL. First experience on laparoscopic near-infrared fluorescence imaging of hepatic uveal melanoma metastases using indocyanine green. Surg Innov. 2015 Feb;22(1):20–25. PMCID: PMC4257891

9.   Hutteman M, van der Vorst JR, Mieog JSD, Bonsing BA, Hartgrink HH, Kuppen PJK, Lowik CWGM, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Near-infrared fluorescence imaging in patients undergoing pancreaticoduodenectomy. Eur Surg Res Eur Chir Forsch Rech Chir Eur. 2011;47(2):90–97. PMCID: PMC3130979

10.   Tummers QRJG, Boogerd LSF, de Steur WO, Verbeek FPR, Boonstra MC, Handgraaf HJM, Frangioni JV, van de Velde CJH, Hartgrink HH, Vahrmeijer AL. Near-infrared fluorescence sentinel lymph node detection in gastric cancer: A pilot study. World J Gastroenterol. 2016 Apr 7;22(13):3644–3651. PMCID: PMC4814650

11.   Handgraaf HJM, Boogerd LSF, Verbeek FPR, Tummers QRJG, Hardwick JCH, Baeten CIM, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Intraoperative fluorescence imaging to localize tumors and sentinel lymph nodes in rectal cancer. Minim Invasive Ther Allied Technol MITAT Off J Soc Minim Invasive Ther. 2016;25(1):48–53. PMID: 25950124

12.   Verbeek FPR, Tummers QRJG, Rietbergen DDD, Peters AAW, Schaafsma BE, van de Velde CJH, Frangioni JV, van Leeuwen FWB, Gaarenstroom KN, Vahrmeijer AL. Sentinel Lymph Node Biopsy in Vulvar Cancer Using Combined Radioactive and Fluorescence Guidance. Int J Gynecol Cancer Off J Int Gynecol Cancer Soc. 2015 Jul;25(6):1086–1093. PMCID: PMC4478233

13.   Schaafsma BE, Verbeek FPR, Elzevier HW, Tummers QRJG, van der Vorst JR, Frangioni JV, van de Velde CJH, Pelger RCM, Vahrmeijer AL. Optimization of sentinel lymph node mapping in bladder cancer using near-infrared fluorescence imaging. J Surg Oncol. 2014 Dec;110(7):845–850. PMCID: PMC4221406

14.   Verbeek FPR, Troyan SL, Mieog JSD, Liefers G-J, Moffitt LA, Rosenberg M, Hirshfield-Bartek J, Gioux S, van de Velde CJH, Vahrmeijer AL, Frangioni JV. Near-infrared fluorescence sentinel lymph node mapping in breast cancer: a multicenter experience. Breast Cancer Res Treat. 2014 Jan;143(2):333–342. PMCID: PMC3899688

15.   Gilmore DM, Khullar OV, Jaklitsch MT, Chirieac LR, Frangioni JV, Colson YL. Identification of metastatic nodal disease in a phase 1 dose-escalation trial of  intraoperative sentinel lymph node mapping in non-small cell lung cancer using near-infrared imaging. J Thorac Cardiovasc Surg. 2013 Sep;146(3):562–70; discussion 569-570. PMCID: PMC3748170

16.   Schaafsma BE, Verbeek FPR, Rietbergen DDD, van der Hiel B, van der Vorst JR, Liefers GJ, Frangioni JV, van de Velde CJH, van Leeuwen FWB, Vahrmeijer AL. Clinical trial of combined radio- and fluorescence-guided sentinel lymph node biopsy in breast cancer. Br J Surg. 2013 Jul;100(8):1037–1044. PMCID: PMC3681835

17.   Gilmore DM, Khullar OV, Gioux S, Stockdale A, Frangioni JV, Colson YL, Russell SE. Effective low-dose escalation of indocyanine green for near-infrared fluorescent  sentinel lymph node mapping in melanoma. Ann Surg Oncol. 2013 Jul;20(7):2357–2363. PMID: 23440551

18.   Schaafsma BE, Verbeek FPR, van der Vorst JR, Hutteman M, Kuppen PJK, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Ex vivo sentinel node mapping in colon cancer combining blue dye staining and fluorescence imaging. J Surg Res. 2013 Jul;183(1):253–257. PMCID: PMC3824623

19.   van der Vorst JR, Schaafsma BE, Verbeek FPR, Swijnenburg RJ, Hutteman M, Liefers GJ, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Dose optimization for near-infrared fluorescence sentinel lymph node mapping in patients with melanoma. Br J Dermatol. 2013 Jan;168(1):93–98. PMCID: PMC3607940

20.   van der Vorst JR, Schaafsma BE, Verbeek FPR, Keereweer S, Jansen JC, van der Velden L-A, Langeveld APM, Hutteman M, Lowik CWGM, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Near-infrared fluorescence sentinel lymph node mapping of the oral cavity in head and neck cancer patients. Oral Oncol. 2013 Jan;49(1):15–19. PMCID: PMC3608510

21.   Schaafsma BE, van der Vorst JR, Gaarenstroom KN, Peters AAW, Verbeek FPR, de Kroon CD, Trimbos JBMZ, van Poelgeest MIE, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer. Gynecol Oncol. 2012 Oct;127(1):126–130. PMCID: PMC3432653

22.   van der Vorst JR, Schaafsma BE, Verbeek FPR, Hutteman M, Mieog JSD, Lowik CWGM, Liefers G-J, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Randomized comparison of near-infrared fluorescence imaging using indocyanine green and 99(m) technetium with or without patent blue for the sentinel lymph node procedure in breast cancer patients. Ann Surg Oncol. 2012 Dec;19(13):4104–4111. PMCID: PMC3465510

23.   van der Vorst JR, Hutteman M, Gaarenstroom KN, Peters AAW, Mieog JSD, Schaafsma BE, Kuppen PJK, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping in cervical cancer patients. Int J Gynecol Cancer Off J Int Gynecol Cancer Soc. 2011 Nov;21(8):1472–1478. PMCID: PMC3202695

24.   Hutteman M, van der Vorst JR, Gaarenstroom KN, Peters AAW, Mieog JSD, Schaafsma BE, Lowik CWGM, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar  cancer. Am J Obstet Gynecol. 2012 Jan;206(1):89.e1–5. PMCID: PMC3246078

25.   Mieog JSD, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers G-J, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJK, Ashitate Y, Lowik CWGM, Smit VTHBM, Oketokoun R, Ngo LH, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483–2491. PMCID: PMC3139732

26.   Hutteman M, Mieog JSD, van der Vorst JR, Liefers GJ, Putter H, Lowik CWGM, Frangioni JV, van de Velde CJH, Vahrmeijer AL. Randomized, double-blind comparison of indocyanine green with or without albumin  premixing for near-infrared fluorescence imaging of sentinel lymph nodes in breast cancer patients. Breast Cancer Res Treat. 2011 May;127(1):163–170. PMCID: PMC3667709

27.   Hutteman M, Choi HS, Mieog JSD, van der Vorst JR, Ashitate Y, Kuppen PJK, van Groningen MC, Lowik CWGM, Smit VTHBM, van de Velde CJH, Frangioni JV, Vahrmeijer AL. Clinical translation of ex vivo sentinel lymph node mapping for colorectal cancer using invisible near-infrared fluorescence light. Ann Surg Oncol. 2011 Apr;18(4):1006–1014. PMCID: PMC3052497

28.   Troyan SL, Kianzad V, Gibbs-Strauss SL, Gioux S, Matsui A, Oketokoun R, Ngo L, Khamene A, Azar F, Frangioni JV. The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in breast cancer sentinel lymph node mapping. Ann Surg Oncol. 2009 Oct;16(10):2943–2952. PMCID: PMC2772055

FDA Expanded Access Policy

At Curadel Surgical Innovations, Inc. we aspire to improve human surgery by visually enhancing anatomy of every kind with FLARE® drugs. The technology we’ve developed uses low levels of invisible near-infrared (NIR) fluorescent light and NIR cameras available in most hospitals around the world to highlight any structure in the body that could help the surgeon perform better surgery. We are currently conducting clinical trials on our products, aiming to obtain regulatory approval to make this technology available to all patients as quickly as possible. As such, we believe that participation in our clinical trials is the most appropriate way to access FLARE® drugs at this time. Information about our clinical trials, including eligibility criteria and locations, is available at https://www.clinicaltrials.gov.

 

Curadel Surgical Innovations, Inc. understands the interest of patients and surgeons in accessing FLARE® drugs outside of clinical trials and prior to regulatory approval, however, we do not currently offer any Expanded Access Programs.

 

PIPELINE

 

Curadel Surgical Innovations has over 300 unique compositions of matter in its contrast agent library. 40 of these drugs have already been validated in preclinical model systems. The following 4 drugs are in active clinical development, with two having already completed Phase 1 and Phase 2 clinical trials.

Careers

 

Currently, no positions are available.

Contact

Contact us

Address:
 

 

 

Phone:
Fax:

Curadel Surgical Innovations, Inc

11 Erie Drive

Natick, MA 01760

 

+1 508-305-2355

+1 508-251-2029