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Company Background

AcuityBio is a preclinical stage company focused on the commercialization of the company’s unique biocompatible, biodegradable drug delivery platform technology to prevent post-surgical locoregional tumor recurrence in early-stage lung cancer patients. AcuityBio’s formation in 2010 stemmed from a collaboration between lung cancer thoracic surgeon Dr. Yolonda Colson (Brigham and Women’s Hospital) and Professor of Chemistry/Biomedical engineering Mark Grinstaff (Boston University). Together with Drs. Grinstaff and Colson, AcuityBio was co-founded in 2010 with CEO Jay Schwartz, Ph.D., and co-inventor of the technology and Director of Research, Jesse Wolinsky, Ph.D. AcuityBio currently has two full-time employees.

Technology Overview

AcuityBio has developed chemotherapy-eluting ABC Mesh™ based on their proprietary slow-release, biodegradable ABC Polymer™ for the prevention of locoregional lung cancer recurrence. It functions by delivering paclitaxel locally at a slow and predictable rate directly at the resection site following lung cancer tumor removal surgery. This maintains a localized high level of drug while minimizing side effects without affecting healing, which will result in better patient outcomes. AcuityBio is currently evaluating applying ABC MeshTM to select soft tissue orphan oncology indications that have a high recurrence rate. This will allow a shortened time through a first-in-human trial as an “orphan” indication and accelerated FDA approval. AcuityBio has developed ABC Mesh to the preclinical stage, focusing on Chemistry Manufacturing and Control, engineering, and securing key manufacturing and supplier CMO/CRO vendor relationships. 

Market Potential

Lung cancer is responsible for more deaths annually in the U.S. than breast, colorectal, and prostate cancers combined. Surgical removal of the tumor (resection) is the standard of care for early-stage lung cancer patients, yet lethal, locoregional tumor recurrence continues to afflict about half of the 50,000 patients per year who receive surgical treatment with curative intent. 

Each year in the U.S., 221,000 new lung cancer cases are reported. Roughly one-quarter of these patients (about 50,000/year in the U.S.) will be considered candidates for surgical resection (the standard of care). The cost to the health care system resulting from the 50 percent endemic cancer treatment failure in the U.S. alone is a staggering $1 to $2 billion per year. Other early stage cancers also suffer from high locoregional recurrence rates, including stage II colorectal cancer (50,000 patients) and breast cancer lumpectomy patients (71,000). Several soft tissue “orphan” oncology indications more than 50,000 patients per year.

Competitive Advantage

Existing drug-eluting polymer products on the market do not possess the properties that are required for the development of an ideal soft tissue compliant, biocompatible, biodegradable drug-eluting implant with tunable drug release. ABC Mesh has all these features. ABC Mesh is an easy-to-manufacture, widely applicable drug delivery platform, which can predictably and locally deliver insoluble and water-sensitive drugs to soft tissue for more than 50 days. The implant has already been proven to be biocompatible (ISO10993), biodegradable, and physically compliant and capable of slow, controlled drug delivery.

Financial Overview

AcuityBio has received almost $3 million in non-dilutive capital through NIH, SBIR Phase I and II, government and Coulter Foundation grants, which will be sufficient to advance their ABC MeshTM program to a first IND. The company seeks $3.5 million to help propel its first product through preclinical and to Phase I safety trials for early-stage non-small-cell lung cancer and to support the clinical development of its orphan drug first-in-human trials

Intellectual Property

AcuityBio has negotiated with Boston University and Brigham and Woman’s Hospital-Harvard/Partners to obtain exclusive world-wide rights to issued patent (U.S. 7,671,095) and three pending patents covering compositions and methods of use. The company has determined it will have a freedom to operate clear of prior art.

Commercialization Strategy

The value proposition of ABC Mesh is that it combines clinical differentiation, ease of use, and positive patient impact at lower overall cost per patient. Thoracic surgeons, hospital purchasing agents, group purchasing organizations will be the company’s main customers. Customers will be compelled to choose ABC Mesh because of its compelling clinical data, key opinion leader, and contract sales channels. 

Pipeline Products

ABC Mesh is a platform technology that has been specialized to deliver water-insoluble or water-sensitive drugs that are traditionally difficult to formulate for administration. The company can tune the drug release rate and the implant’s degradation rate depending on the application. AcuityBio is actively pursuing other clinical indications including orphan indication that would benefit from their localized delivery technology. 

Management Team

John ‘Jay’ Schwartz, Ph.D., Co-Founder, CEO, and Chairman, has more than 20 years in life sciences technology development. He was research faulty at MIT working on drug delivery, is experienced in private equity fundraising, and has succeeded in securing multiple U.S. government grants. He co-founded the venture-backed engeneOS, bought by ADNEXUS, which was acquired by Bristol-Myers Squibb in 2007. Jay received his Ph.D. in Biochemistry and Molecular Biology from New York Medical College and pursued postdoctoral work at Harvard and MIT in drug delivery, protein engineering, and cardiovascular medicine.

Jesse Wolinsky, Ph.D., Co-Founder and Director of Research, is a co-inventor of the ABC Mesh. He holds a doctorate in Biomedical Engineering from Boston University and a Bachelor of Science in Materials Science and Engineering from the University of Florida where he specialized in Polymer Chemistry. 

Company Background

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of cancer based on its patented biophotonic technology. Guided was founded in 1994 and went public via an IPO in 1997 as SpectRx, Inc. The company is the developer of the BiliChek® Non-invasive Bilirubin Analyzer, which uses spectroscopy to measure bilirubin in infants. That product is now sold by Philips Medical. The company changed its name to Guided Therapeutics in 2007 to focus on developing its cancer detection platform. Guided Therapeutics has 38 employees. 

Technology Overview

LuViva is a diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. Unlike Pap, HPV tests, or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful, and unnecessary testing. LuViva is currently approved for use in Canada and is under PMA review in the U.S. and CE mark review in the European Union.

Market Potential

LuViva is designed for use in women who have undergone initial Pap test screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix followed by histopathological examination of the biopsy specimen. LuViva is designed to triage patients to help physicians determine if a woman should undergo a colposcopy exam. About 55 million American women undergo Pap tests with 5 percent to 10 percent requiring follow up. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.

Competitive Advantage

LuViva’s advantages over existing methods include immediate results, no painful tissue samples and no lab-based infrastructure required. In addition to detecting precancer up to two years earlier than the current standard of care, LuViva has been shown to reduce the number of unnecessary procedures.

Financial Overview

In addition to grants from NCI, the company raises additional funding through partnering, contract work and the sale of equity. In 2011, the company raised $6.2 million through these methods. Since its inception in 1993, the company has raised approximately $78 million. The company anticipates requiring approximately $3 to $5 million for an initial product launch.

Intellectual Property

Guided Therapeutics has 16 issued patents pertaining to the technology platform.

Commercialization Strategy

In the U.S., Guided Therapeutics plans a mix of dedicated sales force and selected regional distributors. Internationally, the company is employing country-specific or regional distributors with an established presence in the gynecological market.

Pipeline Products

Guided Therapeutics has entered into a partnership with Konica Minolta Opto to develop a non-invasive test for early esophageal cancer in patients with Barrett’s Esophagus using the biophotonic technology platform.

Management Team

Mark L. Faupel, Ph.D., President, Chief Executive Officer and Director has more than 25 years of experience as a senior executive developing non-invasive alternatives to surgical biopsies and blood tests, especially in the area of cancer screening and diagnostics. Prior to coming to SpectRx in 1998 as Vice President of Business Development and then co-founding Guided Therapeutics, Dr. Faupel was a senior executive and co-founder of Biofield Corp. In 2007, he became President and CEO of Guided Therapeutics.

Richard L. Fowler, Sr. Vice President, Engineering is responsible for identifying new technical and business opportunities for Guided Therapeutics. These opportunities include new technologies, product lines, or business acquisitions that are strategic to the company's business. Mr. Fowler was formerly VP of Engineering at Guided Therapeutics where he oversaw the successful development of the BiliChek® Non-invasive Bilirubin Analyzer.

Shabbir Bambot, Ph.D. Vice President, Research and Development, is a co-founder of Guided Therapeutics. He has 20 years of experience in developing medical diagnostic products and is co-inventor of the technology behind the company’s cancer diagnostic products. He currently manages the development of the company’s esophageal cancer surveillance product in partnership with Konica Minolta Opto, Japan.

Company Background

Michael Curley, Ph.D., and Patrick Hamilton, Ph.D., incorporated Thermedical in Delaware in 2008 to develop, manufacture, and sell thermal therapy devices. They have been collaborating since they met at the Massachusetts Institute of Technology’s Hyperthermia Center, and they have a unique and detailed understanding of biologic heat transfer. The company has seven employees.

Technology Overview

Thermedical’s first product, SERF Ablation therapy for liver cancer, has a 510(k) application pending with the FDA. Thermedical is taking a revolutionary approach to tumor thermal ablation by altering the physics of heat transfer in tissue. SERF Ablation transports thermal energy deep into tissue using convection of warm saline, which carries the heat through the extracellular space. The tissue is transformed from having the insulating properties of wood to conducting heat as efficiently as bronze. Radiofrequency (RF) energy then heats the transformed tissue, and can thereby treat 100 times the volume of tissue that conventional RF can heat. Thermedical has demonstrated that SERF Ablation can treat an 8-cm diameter liver tumor in five minutes.

Market Potential

SERF Ablation for Liver Cancer will extend a treatment therapy for small tumors—RF Ablation—to the 80 percent of patients with tumors larger than 3 cm. The 1.3 million patients annually diagnosed with these large tumors have no cure available to them and live less than one year. This market is significant, with $1.8 billion spent annually on palliative therapies for these patients.

The markets for follow-on products are even more substantial. SERF Ablation will be curative for Ventricular Tachycardia (VT), and will be a disruptive technology for the $7 billion Implantable Cardioverter Defibrillator market. SERF Ablation for fibroids is an alternative to hysterectomy and may restore fertility in the 300,000 women who present with fibroids annually in the U.S. 

Competitive Advantage

Thermedical’s competitive advantage is their expertise on biologic heat transfer and their techniques for increasing heat transfer in tissue. Tissue does not conduct heat well, so existing ablation systems overheat tissue near the energy applicators. These products create hot-spots, islands of therapy in a sea of untreated tissue. SERF Ablation addresses the source of the problem. Warm saline transport increases the heat transfer capacity of tissue by a factor of more than 20, and can quickly and uniformly heat very large volumes of tissue — up to 8 cm diameter — using a single RF applicator. SERF Ablation is uniquely capable of treating conditions that require ablation of large volumes of tissue.

Financial Overview

Thermedical has been funded through NCI and NHLBI grants ($9.0 million) and a grant from the Massachusetts Life Sciences Center ($500,000). With these funds the company has brought SERF Ablation to a 510(k) application. Thermedical has just received its Series A investment from Dr. Samuel H. Maslak, the founder and former CEO of Acuson, the pioneering developer of modern ultrasound imaging systems, acquired by Siemens in 2001. These funds will be used for expanded regulatory clearances. Thermedical seeks funds for human clinical trials of their liver cancer ablation system.

Intellectual Property

Thermedical’s technique is protected by U.S. Patent #6,328,735. The company has filed four additional patents and two trademarks.

Commercialization Strategy

Thermedical will sell direct in the U.S., building a strong training program to ensure that physicians understand the technology. The company will use this approach in Europe for product introduction, but will shift to distributors once the product is established. Thermedical plans to use distributors in the rest of the world. 

Pipeline Products

New SERF Ablation therapies will be built around the company’s SERF Ablation system, which can be used to treat a variety of conditions using therapy-specific applicators. The SERF Ablation system and needle for treating liver cancer are undergoing FDA 510(k) review. The company has also completed a preclinical prototype of their VT ablation catheter, which is undergoing successful preclinical testing. The gynecological application for treating fibroids is in design development. Clinical collaborators for all three applications are enthusiastic about bringing these new tools into the clinic.

Management Team

Michael Curley, Ph.D., President, is the inventor of SERF Ablation Therapy. Dr. Curley previously founded Acuson’s Interventional Devices Business Unit and was its Vice President and General Manager with full profit and loss responsibility. He invented the AcuNav™ Diagnostic Ultrasound Catheter and led its successful introduction to the electrophysiology and interventional cardiology markets; the AcuNav has accumulated more than $1.0 billion in sales to date. His graduate research focused on thermal therapy for cancer. He holds S.B., S.M, and Ph.D. degrees from MIT.

Katharine M. Stohlman, Chief Operating Officer and VP Regulatory and Clinical Affairs was VP of QA and Regulatory Affairs for Viacor, Inc., from 2002 to 2011 and held operational management positions with HP Medical Products Group from 1983 to 2002, with direct reports of more than 200 employees. She holds an S.B. from MIT and an MBA from Harvard Business School.

Patrick S. Hamilton, Ph.D., Founder and VP Engineering, has considerable experience designing and implementing hardware and software for diagnostic and therapeutic medical systems. Dr. Hamilton holds an S.B. from MIT and M.S. and Ph.D. degrees from the University of Wisconsin.