Biosight, LLC and MIT United States

Biosight, LLC  is a start-up biomedical device company developing a low-cost technology that will enable health care providers (HCPs) to discriminate amongst different types of tissues so that they will no longer need to use the blind and semi-blind approach to procedural instrument placement. The key intellectual capital of Biosight, LLC, (Biosight) is medical procedure needle tip tissue identification using multimodal spectroscopy (MMS) technologies first developed in the Laser Biomedical Research Center (LBRC) at the Massachusetts Institute of Technology. Several founding members of Biosight are the pioneers in this field and have established collaborations with clinicians at the Massachusetts General Hospital to identify clinical areas for this technology. Currently, Biosight, LLC is working with several investors in Massachusetts to further develop the device for numerous clinical applications

Year Founded
2014
Main Sector
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Alliance & Collaborations
Massachusetts Institute of Technology and Massachusetts General Hospital
Current Financing Needs
$10M
IP Status
Application Filed
Recent Milestones
Finalist in MIT 100K Pitch 2014
Management Team Highlights
Harvard and MIT Collaborators
Cheryl Campbell
Cheryl Campbell
LinkedIn logo MIT MBA Student and Intellectual Property Attorney 
BIO

A cancer scientist, corporate/IP lawyer and MBA candidate at the MIT Sloan School of Management who is dedicated to commercializing innovative biopharmaceutical products and medical devices that benefit patients. I have acquired diverse experience in the health care and life sciences industries spanning discovery, commercialization and regulatory development. My goal is to create and execute business and legal strategies that successfully drive products to market and create overall value for patient care. Capabilities include research design, assay development, clinical trial management, market/financial analysis, data modeling, operational design and management, system dynamics, drafting regulations, stakeholder engagement, intellectual property, licensing and contract drafting/negotiations.

Biosortia Pharmaceuticals United States

Biosortia has opened the door to a new frontier of fascinating compounds that have the potential to materially impact the direction of various chronic diseases.  We are dedicated to discovering new chemical entities for the management of critical chronic disease states such as cancer, neuroscience, infectious disease, and inflammatory disorders to ultimately improve the lives of others.

Value Proposition

Pharma is looking for 3 key things:

1. Novel, never seen before, chemistry from new environments to fight chronic disease

2. Higher levels of potency (nano to Pico molar) to reduce the impact of side-effects

3. New mechanisms of action to fight chronic disease in new and more effective manner

It is well known that micro-organism consortia (not macro) are one of the most biologically active and chemically diverse plant/fungi that are rich in what we call “Defense Mechanism Chemistry”.  Defense Mechanism Chemistry is key in developing drugs for cancer, infectious disease and inflammation.  The problem is no one has been able to get access to this unique chemistry at scale and have the natural products expertise to identify the unique compounds…until now.  

We will provide Pharma with new compounds, rich in “Defense Mechanism Chemistry” on a routine basis that could shorten the discovery cycle by 2-3 years and reduce the overall cost.  

Best Regards,

Kurt Dieck

President and CEO

kdieck@biosortia.com

(614) 296-7076

Year Founded
2008
Biotech Subsector
Biotech Phase of Development
Technology Overview
Mobile, scalable, technology that maintains the integrity of the cell. Biosortia has proprietary methods & technologies that allow us to harvest unique single cellular micro-organism consortia never before studied and in unprecedented quantities targeting 500-1,000kg dry weight solids (DWS). Our technologies and capabilities open up this rich environment of bioactive and chemically diverse compounds for research in the pharmaceutical space for the first time ever. Biosortia’s relationship with NOAA and our Cooperative Research and Development Agreement (CRADA) with them provides Biosortia with identification and access to distinctly qualified harvest locations.
Alliance & Collaborations
(Eli Lilly, AstraZeneca, Eisai and Cubist Pharmaceuticals) with more in the pipeline.
Supporting Metrics or Evidence
Promising Early Results with big pharma (Eli Lilly, AstraZeneca, Eisai and Cubist Pharmaceuticals) with more in the pipeline. • Eli Lilly’s OIDD To date, nearly 100% of Compounds of Interest submitted into Eli Lilly’s Open Innovation Drug Discovery (OIDD) program have been accepted for evaluation…compared to an average 50-60% rejection rate on all submissions. This unprecedented achievement has recently earned Biosortia the inaugural “Collaborator of the Year” award from Lilly. In addition, due to the success in the OIDD Program, Lilly asked to join our Pharma Direct Model and test our fraction library. Initial results across simple 2 assays have produced 10 leads that they desire to follow-up in December 2014. • Big Pharma Interest As of September 30, 2014 we have 4 Big Pharma companies in our Pharma Direct Model (Eli Lilly, AstraZeneca, Cubist and Eisai) with 3 others in the pipeline in various stages of discussions.
Current Financing Needs
Capital- Biosortia has raised 2 rounds of series A Preferred Shares; November 2012 of $1.1M ($29M pre-money valuation) and September 2013 of $3.9M ($35M pre money valuation). In addition, it secured $1 million loan (2% interest) from the State of Ohio, therefore meeting our original desired capital raise of $4-5 million. The current raise is for $3-$6 million dollar to provide the runway to our first licensing agreement in Q4 2015 and drive the scaling of science capability to support the volume from our fraction libraries to be launched in Q1 of 2015.
Current Timeline
Hit rates well in excess of expectations Through our Pharma Direct Partners and 8 academic collaborators, we have over 50% of our fractions active against various therapy areas. This demonstrates both the richness of our compounds and the diversity across multiple therapy areas. With one of our Big Pharma partners alone, we have 48 active fractions/wells, with 20 showing inhibition of cancer growth from 90-99.8%. • Clear pathway to first license event in 2015 We can share with you a clear pathway to a license event in 2015. AZ, Lilly and Eisai are all on schedule to complete their R&D efforts by Q3 of 2015 that will put them in position to determine which compounds of interest they would like to license.
Recent Milestones
To date, nearly 100% of Compounds of Interest submitted into Eli Lilly’s Open Innovation Drug Discovery (OIDD) program have been accepted for evaluation…compared to an average 50-60% rejection rate on all submissions. This unprecedented achievement has recently earned Biosortia the inaugural “Collaborator of the Year” award from Lilly.
Management Team Highlights
Experienced Leadership Team & Advisors Biosortia’s leadership team has over 135 years of healthcare and life science experience with expertise in both pharmaceutical research and the micro-organism aquatic environments with the capability to provide new chemistry in a research ready format and co-develop with Pharma to pre-clinical. -Kurt D. Dieck, President and CEO - Mr. Dieck has spent 30 years in healthcare, including 18 years at Arthur Andersen where he was a global equity partner. In 2002, Kurt joined Cardinal Health, a Fortune 20 public company as a senior executive; where over his tenure he had responsibilities for Strategy, Business Development and ultimately SVP of Business Execution for the $100B pharmaceutical distribution segment. There he worked with a broad spectrum of partners, including brand pharmaceutical manufacturers, throughout the supply chain. Kurt also sits on two other healthcare related boards that are owned by Private Equity firms. -Guy T. Carter, Ph.D., Chief Scientific Officer – Dr. Carter has over 30 years of experience working in Pharmaceutical R&D, primarily in the discovery and development of microbial products. In the course of his career in the pharmaceutical industry he worked as a natural products discovery scientist and advanced through levels of scientific management to the overall leadership of the Natural Products Discovery function at Wyeth Research (later acquired by Pfizer), as well as directing other elements of the Chemical Technologies Department. Guy received a doctorate in Biochemistry from the University of Wisconsin-Madison, and then pursued marine natural products research on an NIH-sponsored post-doctoral fellowship with Kenneth Rinehart at the University of Illinois. -Haiyin He, Ph.D., VP of Research – Dr. He has more than 20 years of experience in pharmaceutical R&D, specializing in discovery of drug leads from natural products and their semi-synthetic analogs in oncology, infectious disease, and other therapeutic areas. Haiyin worked as a principle scientist III and group leader at Wyeth Research and after the merger between Pfizer and Wyeth, he continued on to work at Pfizer World Wide Medicinal Chemistry as an associate research fellow in the area of antibody-drug conjugates for cancer chemotherapy. Haiyin received a doctorate in marine natural products at Scripps Institution of Oceanography with John Faulkner, and then acquired a postdoctoral experience at Chemistry Department, Cornell University with Jon Clardy.
Dr Guy Carter
Dr Guy Carter
LinkedIn logo CSO 
Mr Kurt Dieck
Mr Kurt Dieck
LinkedIn logo President and CEO 

Biotherapeutics inc United States

BioTherapeutics Inc. (BTI) is a pre-clinical stage company developing novel small-molecule drugs to treat inflammation associated with autoimmune related disorders and type 2 diabetes (T2D). We have identified an orally-active, first-in-class top lead compound that targets a unique and novel MoA: the LANCL2 pathway. Our top lead compound has demonstrated extremely positive efficacy in mouse models of both IBD and T2D and our preliminary toxicology data has confirmed that is safe at a very high dose and as a multiple dose for 14 days.

We just closed a very well funded seed round (NIH, CIT Gap Funds, other investments) and we are now looking to raise from $3 to $5M to generate IND enabling data and start human trials.

Dr Adria Carbo
LinkedIn logo Scientific Director 

Brace Pharmaceuticals United States

Brace Pharmaceuticals is based in Rockville, MD, and is a strategic investment company formed by Brazil-based pharma company EMS S/A. Brace investment structure varies depending on a company’s development stage; for early-stage opportunities Brace typically makes equity investments and may syndicate with other investors, whereas for clinical-stage opportunities Brace is more likely to form strategic partnerships that involve rights to an asset. Brace is open to considering therapeutic opportunities globally, but only if the company is pursuing the US market.

Brace Pharmaceuticals invests in therapeutics; about 80% of the firm’s investments are in clinical-stage assets, with a preference for companies with some human proof-of-concept data; the remaining 20% of investments are made in preclinical opportunities. Drug-device combinations will also be considered, but Brace does not invest in diagnostics. The firm will invest in both small and large molecules, and has a strong preference for investing in orphan drugs and other niche disease areas. It is preferred that indications have validated clinical endpoints and can be studied using small trials. Indications that require large clinical trials, including as cardiovascular diseases and primary care indications (such as influenza) will not be considered.

Basheer Zada
Business Development 
Vinzenz Ploerer
President & CEO 
Todd Brady
Director of Finance 

Brio Device, LLC United States

Brio Device, LLC is a medical device company and spin-out of the University of Michigan Medical Innovation Center based in Ann Arbor, MI. Brio develops airway management devices and intubation instruments.

PROBLEM: High Intubation Failure  

There are 20M+ intubations performed in the US every year. Depending on setting and skill of the clinician, failure rates range from 2% - 40% resulting in approximately 2,000,000 intubation failures every year. Intubation, the procedure to insert a plastic tube into the trachea, requires significant expertise and experience to do well.  With current products in the market, the tube often is inserted multiple times before it is properly placed, resulting in damage to the patient such as broken teeth, torn vocal cords, or insertion into the stomach leading to aspiration and pneumonia.  Three main factors affect intubation success rates: the user’s experience level, having directional control of the tube during insertion, and continuous visualization appreciated in bronchoscopes.  Clinicians need a single go-to device which is appropriate for use both in routine intubation and difficult airway cases offering guidance, maneuverability and visualization necessary to be successful. Failed intubation is the most common preventable cause of trauma-related deaths.  Approximately 180,000 deaths per year list complications associated with failed intubation.

SOLUTION: Brio’s Articulating & Video Stylets  

Brio is introducing a suite of products intended to improve intubation success rates for planned and emergent intubations, minimizing reliance on clinician skill for success.  The products range from disposable mechanical devices to devices with imbedded software providing anatomic image recognition guidance for the clinician. The devices have three critical elements to assist users in locating the trachea and maneuvering the endotracheal tube. 

1. Articulating tip with thumb-controlled steering

2. Continuous visualization

3. Visual guidance software 

BUSINESS MODEL

Brio’s core competencies are R&D, product development, sales and marketing of medical devices.  Projections are built on three revenue streams: two disposable stylets (one with and one without a camera) and a reusable video display.   Brio has an agreement with a manufacturing partner to facilitate design history files, regulatory compliance, manufacturing and customer service.

FUNDING  & MILESTONES

Brio has received $815,000 funding, including $690K in non-dilutive grants and $125k in convertible notes.  The Company has received Small Business Investigational Research (SBIR) Grants from the NIH.  

Year Founded
2011
Main Sector
Indication
Medtech Phase of Development
Technology Overview

Brio suite of devices for intubation. The products are used to insert endotracheal tubes and are designed for first-attempt intubation success.

Key Features

  • Software algorithm recognizes anatomical landmarks and displays labels on video screen
  • Software displays optimal position of sytlet tip with a white “x” as the stylet advances through the airway
  • Visualization of the tip
  • Tip articulation

 

Benefits

  • Software enhanced visualization
  • Visually confirm success
  • Reduces time to intubate
  • Reduces tissue trauma

Alliance & Collaborations
Brio has its primary office and lab space within the medical device incubator and business accelerator facilities of MC3, Inc. The Company is considered a “Member” of MC3’s Medical Device Business Accelerator. Address: MC3, Inc. 3550 West Liberty, Suite 3, Ann Arbor, Michigan 48103. Manufacturing Partner Brio has an agreement with Summit Medical Products, Inc. based in Sandy, UT. The contract provides Brio with a team of experienced professionals from engineering, manufacturing, regulatory affairs, marketing and sales. Summit is engaged in the business of and possesses expertise with respect to, among other things, the manufacturing, assembling, processing, packaging, approvals and regulatory processes, and sales of medical devices. The strategic partnership Brio has with Summit is to assist in product design and development, process validation, risk management procedures, manufacturing, verification and validation, and quality assurance for the intubation device.
Supporting Metrics or Evidence

There are 20M+ intubations performed in the US every year. Depending on setting and skill of the clinician, failure rates range from 2% - 40% resulting in approximately 2,000,000 intubation failures every year.

Current Financing Needs

Current Financing Round: $1.5M ... Anticipated total paid-in-capital: $4.0M

Current Timeline

Completing design for manufacturing and pilot manufacturing. First generation product, FDA Class I exempt, enters the market in Q2 2015. Follow-on products to enter the market starting Q3 2016.

Current Investors

Convertible Notes: State of Michigan University Commercialization Fund, MC3, Inc., and Summit Medical

IP Status

PCT/US12/36290 submitted May, 2012. National Phase Patent Application Ser. No. 14/115,196 - Filed: Nov. 1, 2013.

Recent Milestones

Prototypes tested by groups of clinicians ranging from Residents to experienced specialists in simulation mannequins. First generation product being converted from 3D prototype to design for manufacturing and pilot manufacturing.

Management Team Highlights

Hannah Hensel, CEO, holds an MBA from the University of Michigan Ross School of Business and has 20+ years business leadership experience. A unique start-up experience for her took place as Sponsorship Sales & Marketing Manager for the 2002 Olympic Winter Games where she reported to Mitt Romney; the organization went from $0 to $1.5B in seven years. Product development for Brio is led by Laura McCormick, PhD in biomedical engineering, Douglas Mullen, PhD in nanotechnology/materials science and Sabina Siddiqui, MD. Brio's Commercialization Officer, Rich Borncamp, is the newest member of the team. He has spent his career launching new medical devices, establishing go-to-market plans nationally and internationally, and negotiating agreements with Group Purchasing Organizations.

Hannah Hensel
CEO 
Rich rborncamp@xmission.com
Commercialization Officer 

Cavidi United States

Cavidi is a Swedish based diagnostic company that has developed a novel method for measuring HIV viral load in patients recieving anti-retroviral therapy for treatment of HIV. Viral load is a critical indicator of the effectiveness of HIV therapy, and has been the standard of care in the developed world for many years. Just recently the World Health Organization (WHO) updated its recommendations to include viral load for patients in the developing world where the vast majority of HIV patients exists, and a large influx of international funding has significantly increased aceess to HIV drugs. The Cavidi method is novel in that it measures the viral enzyme reverse transcriptase (RT), and not viral nucleic acid (RNA) by polymerase chain reaction (PCR). The Cavidi method is not subject to the logistical challenges of PCR such as contamination risk. The Cavidi RT assay is much less expensive and can be performed in labs that lack the sophisitication to perform technologies such as PCR. Therfore, the Cavidi assay significantly improves access to this vitally important technology. For the past several years a manual version of the Cavidi technology has been utilized in laboratories in the developing world. The performance of the assay has been validated vs the industry leading PCR methods in many peer review publications. The company is now seeking funding to develop an automated version of the assay that will make it more widely adaptable to many laborartories. 

Website:
www.cavidi.com
Year Founded
2007
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Technology Overview
Cavidi's novel IVD technology uses Reverse Transcriptase(RT) as a marker for measuring replication competent HIV in blood (HIV viral load). Measuring viral load in HIV patients receiving anti viral therapy is now a global World Health Organization recommendation. Unlike PCR tests, Cavidi's RT assay requires minimal resources & lab footprint, can measure all subtypes of HIV, and at half the cost or less of PCR tests. The technology has been proven in over 400,000 tests in 50 markets worldwide.
Alliance & Collaborations
• Johns Hopkins School of Medicine, Uganda • Burnet Institute, Australia • University of Maryland School of Medicine IHV (Institute of Human Virology) • Karolinska Hospital, Sweden • SIDA (Swedish International Development Cooperation Agency) • Royal Free Hospital, London, UK • Harvard AIDS Institute Partnership, Botswana- • New York University School of Medicine, Kenya • Swedish Institute for Infectious Disease Control, Sweden • Virus Reference Depart
Supporting Metrics or Evidence
The Cavidi ExaVIr Load assay has been widely cited in peer review publications, and favorably compared to industry standard PCR technology. In addition to routine HIV viral load measurement, the Cavidi RT assay has demonstrated favorable performance vs. industry standard PCR for early infant HIV diagnostic (EID) market. ExaVir™ assay showed excellent concordance with real-time molecular assays Abbott M2000sp and Roche Cobas TaqMan...Journal of Clinical Microbiology 47(10): 3266-3270
Current Financing Needs
Development project completion 2015 $7M + 2016 $3M =$10M Global product launch 2016 $3M + 2017 $2M=$5M
Current Timeline
Next generation of fully automated HIV viral load test development project started in 2102. Prototype 1 and 2 now working. OEM selected Q12015, validation and verification of final design Q22015, Distribution Partner selection by Q22015, pre-series Q42015, serial production start Q12016, and CE Registration Q22016. Cash flow positive 2017.
Current Investors
Two private US investors hold majority interest
IP Status
IP is strong and broad covering key aspects of the technology methods with over 100 international patents in five patent families.
Recent Milestones
• Awarded SWECARE Export Award by Swedish MOH May 2013 • Supply Agreement signed with Load Zero Foundation in June 2013 • Presentation at UN Global Health Impact Forum May 2014 • TECH20 award as top 20 (2%) of 800 startups in Sweden June 2014 • UNITAID grant LOI accepted (3/12) June 2014, Full Application grant pending Dec. 2014 • POLS/One Technology evaluation meta study (2/2014) ranks Cavidi ExaVirLoad with top global diagnostic comp
Management Team Highlights
Experts in diagnostic technology development covering: Clinical Assay Chemistry, Devices, Instruments, Software, System Integration, QA & QC, Regulatory Strategy. Commercial scale up of new technologies in global markets with focus on emerging markets in Africa and Asia. Capital raising for start up and early stage companies.
Bob Barrett
Global Head, Business Development 

Celling Biosciences United States

Regeneration Through Innovation

Celling Biosciences is dedicated to researching and developing the future of healing through regenerative medicine and the clinical use of autologous regenerative cells to facilitate the body’s capacity to heal itself. Through our patented Celling therapies and our Institutes of Regenerative Medicine, Celling Biosciences is moving the science of healing forward and redefining the global medical landscape.

Year Founded
2006
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview
Regeneration Through Innovation

Celling Biosciences is dedicated to researching and developing the future of healing through regenerative medicine and the clinical use of autologous regenerative cells to facilitate the body’s capacity to heal itself. Through our patented Celling therapies and our Institutes of Regenerative Medicine, Celling Biosciences is moving the science of healing forward and redefining the global medical landscape.

Current Financing Needs

$3-10 million growth capital with opportunity for partial founder buy-out.

Management Team Highlights
Kevin Dunworth

Founder / CEO

Kevin Dunworth, Founder of Celling Biosciences, has spent more than 26 years in the orthopedic industry and brings a wealth of expertise in all aspects of the business. Dunworth has run medical companies in the Middle East, Eastern and Western Europe, and the United States.

He excelled in various executive positions before founding VCD Medical, in Austin, Texas.
For the past eight years, Dunworth has successfully built a world-class distribution business, which provides a variety of orthopedic and biologic products.

Dunworth's leadership roles within the orthopedic industry have included, Director of Emerging Markets and Director of European Sales for Smith & Nephew; Director of International Sales, Vice President of Worldwide Sales and Vice President for FlouroScan International and Vice President of Sales for TransLeasing and Vice President for TransLeasing GE.


Steve Melchiode

President
Steve Melchiode has extensive experience guiding businesses from start-up to profitability. After earning an undergraduate marketing degree followed by a law degree, Melchiode joined a start-up technology firm in Silicon Valley as the West Coast business development director. Melchiode's ability to build and lead successful companies, combined with his experience in medical device sales, provides him with the vision and expertise to lead the Celling Biosciences team. He brings a wide range of experience in sales, business development, marketing, finance, legal and operations management.

Melchiode began his medical device career as a sales representative with VCD Medical, learning the spinal implant industry selling Depuy Spine. After two years spent growing several new territories, Melchiode established himself in a leadership role as sales manager and by running operations for the State of Texas. For the past two years, he has worked with Kevin Dunworth to take the Celling Biosciences model from concept to market, working on business, product and partnership development as well as marketing and operations.

Mr Blair Duncan
Mr Blair Duncan
LinkedIn logo Chief Financial Officer 
BIO

Blair Duncan, Chief Financial Officer, Celling Biosciences

 

Mr. Duncan has over 20 years experience in venture-backed growth companies, as well as Fortune 500 and service firms. Before joining Celling Biosciences, Mr. Duncan was Chief Financial Officer at Emergent Technologies, an early stage life sciences commercialization operator and venture capital firm.  Previously, Mr. Duncan was Chief Financial Officer and Controller at SiteStuff, a leading provider of online procurement services for the commercial real estate industry.  Prior to SiteStuff, Mr. Duncan was Chief Financial Officer for Trillion, a facilities-based provider of wireless broadband telecommunications services to K-12 school districts.  Mr. Duncan also served as Vice President and Controller for ClearSource, a facilities-based provider of broadband telecommunications services.  Mr. Duncan held positions at PricewaterhouseCoopers as Manager of Entrepreneurial Advisory Services, where he launched a new division providing fundraising and business planning consulting services to high-tech companies in Texas, as well as Manager in the Business Assurance practice, where he participated in numerous public offerings and private company audits.  Mr. Duncan started his career with Aetna as a manager of property and casualty underwriting and business development. 

 

Mr. Duncan is a CPA and holds a MBA from the University of Texas at Austin.  He has a BA in Economics and Psychology from Duke University. Mr. Duncan enjoys travel, music, tennis and golf.  He is Career Services Chair of the Financial Executives International – Austin Chapter, as well as Treasurer of the Maya Exploration Center.  He is married with three children and resides in Austin, Texas.

Ciclofilin United States

A biopharmaceutical company specializing in development 
of cyclophilin inhibitors, an emerging class of drugs for infectious, inflammatory, and degenerative diseases.

Focus:  Many hepatitis B and C patients fall into difficult-to-treat categories due to more complicated liver disease and poorer responses to treatment.  One major group is coinfected patients (HCV/HIV-1 or HCV/HBV), who are more prone to develop end stage liver disease and liver cancer than monoinfected patients.  Patients with cirrhosis represent a second major group. Cyclophilin inhibitors, having broad-spectrum antiviral, anti-inflammatory, and anti-fibrotic activities are excellent candidate medicine for these difficult-to-treat  patients. 

Year Founded
2014
Biotech Subsector
Biotech Phase of Development
Technology Overview
Cyclophilin Inhibition: antiviral and liver disease
Alliance & Collaborations
NRC (Canada), Scripps Research Institute (La Jolla, CA), NIH
Current Financing Needs
Angels, VC Series A
IP Status
issued/pending
Recent Milestones
AASLD presentation on HIV/HCV co-infection. Lead molecule, CPI 431-32, kills both viruses simultaneously, and may also mitigate progression of liver disease
Management Team Highlights
Drs. Foster and Ordonez, Founders. Both with decades each of biotechnology and capital market expertise
Robert Foster
CEO 

Clayton Biotechnologies United States

Clayton Biotechnologies commercializes technologies that are developed and owned by the Clayton Foundation for Research and its supporting entities through research programs at leading research hospitals and institutions in the US and Switzerland.

We have several projects in various stages of development from discovery to advanced pre-clinical that are available for licensing, collaboration, and the creation of new start-up ventures.

Clayton Biotechnologies has a significant portfolio of technologies to offer for licensing and collaboration. 

 

Some of our featured technologies:

- Urocortins and analogues for Diabetes

- Fc engineering of aglycosylated antibodies

- Granzyme B - a potent payload for antibody drug conjugates (ADC)

- Alk4-Fc, a Cripto antagonist for Cancer

- TEAD gene and peptide therapies for ocular neovascular disease

- Stem cell therapy program for Parkinson's Disease

- Vaccines and Diagnostics for Ehrlichioses

- Biomarker for personalized breast cancer therapy

- YESS - engineering of proteases

- OCT Image Guided Smart Laser Knife Diagnosis and Therapy in Small Spaces

 

To date, 9 products based on Clayton Foundation discoveries have been have been successfully commercialized through the creation of start-up companies and out-licensing

Alexandra Richardson
Head of Business Development 

CloSys Corporation United States

We have developed the CloSys Hemostatic Device (HD)  - a highly differentiated technology for vascular closure after an interventional cardiology or peripheral procedure.  CloSys HD is unique in that it facilitates rapid closure but leaves NO foreign material behind in the patient.  It does this using a patented technology that eliminates heparin (anti-coagulant) from a small amount of the patient's blood and re-infuses this back to the puncture site and around the entire artery.  The de-heparinized blood rapidly and safely forms a clot to seal the artery naturally.  There are several other unique attributes of this product.  First  - it is the only product that will also seal "backsticks" or inadvertant punctures that go through the other side of the artery.  Backsticks are a leading cause of retroperitoneal hemorrhage.  Second - it preserves immediate re-access at the same site in the advent of an emergency.  

There is also an important economic value proposition offered by CloSys HD.  It will have a very low cost of goods so it could be sold for a price that will allow high margins to the manufacturer and cost savings to the hospital.  

We are approximately 25% of the way through a US pivotal trial and to date all performance and safety endpoints have been met.  There is a highly experienced management team and exceptional Board of Directors now associated with the company.    

Year Founded
2005
Main Sector
Medtech Subsector
Indication
Medtech Phase of Development
Technology Overview
CloSys HD consists a simple to use two component system. One component is a "wall locater" that is deployed inside the artery to achieve temporary hemostasis. The other component is a syringe with a special "reactor" in the tip that contains glass beads coated with a proprietary polymer. Blood withdrawn through the sheath passes through the reactor in the syringe which instantaneously removes heparin from the blood. The de-heparinzed blood is re-infused and forms a clot at the puncture site and around the artery.
Alliance & Collaborations
Rex Healthcare (part of UNC) in Raleigh, NC. Cardiovascular Institute of the South in Lafayette, LA, Deborah Heart and Lung in Brown Mills, NJ, and Mt. Sinai Medical Center in Miami, FL
Supporting Metrics or Evidence
Early results from an IDE trial. In this key performance endpoints of time to hemostasis and time to ambulation are being met. Safety endpoint of no unanticipated adverse events being met too. Results from two earlier studies performed in Europe as well numerous GLP and bench test reports have demonstrated effectiveness and safety.
Current Financing Needs
$4 million to complete trial, submit, obtain regulatory approval
Current Timeline
Approximately 10 months to complete enrollment and follow up, 2 to 3 months to write report, tie up loose ends at study sites and submit to the FDA. Approval time and questions ranges from about 4 months to 9 months.
Current Investors
Mostly angel investors and several smaller institutions such as Iowa Lakes Capital, University of St. Thomas Norris Fund, and Blankney Group from Milwaukee
IP Status
10 issued patents in the US, 3 issued patents in Europe and Canada, one provisional patent filed in the US
Recent Milestones
New members adde to the Board of Directors, meeting with FDA to re-classify to a Class Ii device
Management Team Highlights
Kevin Dillon - CEO and Director, Mary Lach - CFO, Kelly Elliot - Clinical Study Director, John Erb - Director, Warren Watson - Director, Christopher Barys - Director, Steven Zenz - Director, Bruce Johnson - Chairman and Director
Kevin Dillon
Kevin Dillon
CEO