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Technology Name: Closed-System Drug Transfer Device (CSTD)
Company Background
OSHA and NIOSH confirm that over 5.5 million workers are exposed annually to chemotherapy and other hazardous pharmaceuticals during drug preparation and delivery, which studies have shown causes cancers, organ failures, reproductive toxicity, and genetic mutations. Corvida Medical is an emerging device company developing a disposable, Closed-System Drug Transfer Device (CSTD) that provides greater safety and significantly improved usability, enabling healthcare providers to safely deliver the highest quality care to patients. Corvida is led by a management team with experience leading multiple prior medical device companies from start-up to successful exit. Corvida has scheduled the inaugural product unveiling to the public at a hospital pharmacy conference later this year and is on track for FDA 510(k) submittal of its initial CSTD product by end of 2014 and commercialization in 2015.
Technology Overview
Corvida’s 2nd generation CSTD products have new features that optimize containment effectiveness, simplify system configuration, and improve ergonomics. Preliminary data from Corvida’s NCI-funded Phase II Small Business Innovation Research (SBIR) project shows the CSTD meets design and production quality criteria for product performance and has been validated against industry test standards.
Competitive Advantages
Corvida’s innovative CSTD system consists of a set of proprietary disposable components incorporating key differentiators over existing technology that significantly improve safety, effectiveness, and usability.
Market Potential
The global CSTD market is valued at an estimated at $1B total available market, growing ∼20% annually as cancer rates and use of chemotherapy continue to rise. The US hospital segment includes 1,500 leading cancer centers that treat the most patient and are driving the adoption of CSTD technology. Sixty-eight (68) of these facilities achieved an NCI Comprehensive Cancer Center or Cancer Center designation. Given both their high patient volume and prestige, these national Cancer Centers will be targets for Corvida’s initial marketing and sales efforts, and many of these leading cancer centers have committed to collaborating with Corvida Medical on the NCI SBIR Phase II and Phase IIB projects. Beneficiaries of CTSD technology advances include pharmacists, pharmacy technicians, and nurses who prepare and/or administer chemotherapy, other workers who may be inadvertently exposed, and the patients who receive the drugs as well as their family/visitors.
Pipeline Products
Corvida has plans to introduce additional offerings to their CSTD product line. The company pipeline includes further feature development of the CSTD products as well as additional systems that can utilize the CSTD devices. Additional features of the CSTD will address drug administration (nursing) needs, alternate site needs, continued ergonomic improvements, and expansion to a wider category of hazardous drugs. The company is actively developing these pipeline products in tandem with the primary CSTD product offering scheduled to launch later this year.
Financial Overview
Corvida has raised multiple millions of dollars since the company was founded in 2008. The company completed a multi-million Series A Financing in 2011 for R&D, IP development, and initial production. The company is currently raising a
Series B Financing for 510(k) clearance and initial commercialization. Management has secured a lead investor and closed over half of this round of funding to date. Management is working to close the Series B by end of 2014. Management also plans to raise a Series C round to scale operations/manufacturing, which is planned for 2015.
Intellectual Property
Corvida maintains seven (7) issued/allowed utility patents domestically and in foreign jurisdictions, and has 15 PCT utility applications pending. The company also has multiple trademarks, protecting both the company and product brand. Additionally, Corvida has secured a clear freedom-to-operate analysis.
Commercialization Strategy
Corvida is in discussions with several potential strategic partners to distribute their CSTD product once it receives FDA 510(k) clearance. A partner will maximize sales penetration via use of their established sales and marketing organizations. Corvida will initially pursue direct sales and support, starting with pre-market launch Q4 2014 at the major pharmacy conference drawing over 20,000 hospital pharmacists, with a focus on a limited set of prestigious cancer centers. The early launch goal will provide an opportunity to establish reference accounts which will broaden the opportunity to sell to a wider audience. Corvida is collaborating with over 20 leading cancer centers that are participating in the Corvida NCI SBIR Phase II study and are likely to become customers upon completion of the study and receipt of FDA 510(k) clearance.
Management Team
• CEO and President Kent Smith has 30 years of successful global medical device commercialization and business leadership experience, and 10 years of experience in startups. He helped lead a medical device startup from $0 to $30 million with a $310 million acquisition.
• Vice President of Manufacturing Dana Schramm has 20 years of experience in medical device manufacturing, working at companies ranging from $1 million to over $1 billion in sales, and was successful in developing and launching over 50 medical devices.
• Vice President of Research Prasad Sunkara has 35 years of corporate, financing, research, development, and management experience in corporate and startup environments. He has been an officer and/or founder in multiple life science companies, several of which were acquired.
• Co-Founder & CFO John Slump has a BBA in Finance and a background in corporate accounting, fundraising, financial modeling, and capital formation.
• Co-Founder & CTO Jared Garfield has a BBA in Management Information Systems and a background in information technology, engineering, and business management experience.

Technology Name: Closed-System Drug Transfer Device (CSTD)
Company Background
OSHA and NIOSH confirm that over 5.5 million workers are exposed annually to chemotherapy and other hazardous pharmaceuticals during drug preparation and delivery, which studies have shown causes cancers, organ failures, reproductive toxicity, and genetic mutations. Corvida Medical is an emerging device company developing a disposable, Closed-System Drug Transfer Device (CSTD) that provides greater safety and significantly improved usability, enabling healthcare providers to safely deliver the highest quality care to patients. Corvida is led by a management team with experience leading multiple prior medical device companies from start-up to successful exit. Corvida has scheduled the inaugural product unveiling to the public at a hospital pharmacy conference later this year and is on track for FDA 510(k) submittal of its initial CSTD product by end of 2014 and commercialization in 2015.
Technology Overview
Corvida’s 2nd generation CSTD products have new features that optimize containment effectiveness, simplify system configuration, and improve ergonomics. Preliminary data from Corvida’s NCI-funded Phase II Small Business Innovation Research (SBIR) project shows the CSTD meets design and production quality criteria for product performance and has been validated against industry test standards.
Competitive Advantages
Corvida’s innovative CSTD system consists of a set of proprietary disposable components incorporating key differentiators over existing technology that significantly improve safety, effectiveness, and usability.
Market Potential
The global CSTD market is valued at an estimated at $1B total available market, growing ∼20% annually as cancer rates and use of chemotherapy continue to rise. The US hospital segment includes 1,500 leading cancer centers that treat the most patient and are driving the adoption of CSTD technology. Sixty-eight (68) of these facilities achieved an NCI Comprehensive Cancer Center or Cancer Center designation. Given both their high patient volume and prestige, these national Cancer Centers will be targets for Corvida’s initial marketing and sales efforts, and many of these leading cancer centers have committed to collaborating with Corvida Medical on the NCI SBIR Phase II and Phase IIB projects. Beneficiaries of CTSD technology advances include pharmacists, pharmacy technicians, and nurses who prepare and/or administer chemotherapy, other workers who may be inadvertently exposed, and the patients who receive the drugs as well as their family/visitors.
Pipeline Products
Corvida has plans to introduce additional offerings to their CSTD product line. The company pipeline includes further feature development of the CSTD products as well as additional systems that can utilize the CSTD devices. Additional features of the CSTD will address drug administration (nursing) needs, alternate site needs, continued ergonomic improvements, and expansion to a wider category of hazardous drugs. The company is actively developing these pipeline products in tandem with the primary CSTD product offering scheduled to launch later this year.
Financial Overview
Corvida has raised multiple millions of dollars since the company was founded in 2008. The company completed a multi-million Series A Financing in 2011 for R&D, IP development, and initial production. The company is currently raising a
Series B Financing for 510(k) clearance and initial commercialization. Management has secured a lead investor and closed over half of this round of funding to date. Management is working to close the Series B by end of 2014. Management also plans to raise a Series C round to scale operations/manufacturing, which is planned for 2015.
Intellectual Property
Corvida maintains seven (7) issued/allowed utility patents domestically and in foreign jurisdictions, and has 15 PCT utility applications pending. The company also has multiple trademarks, protecting both the company and product brand. Additionally, Corvida has secured a clear freedom-to-operate analysis.
Commercialization Strategy
Corvida is in discussions with several potential strategic partners to distribute their CSTD product once it receives FDA 510(k) clearance. A partner will maximize sales penetration via use of their established sales and marketing organizations. Corvida will initially pursue direct sales and support, starting with pre-market launch Q4 2014 at the major pharmacy conference drawing over 20,000 hospital pharmacists, with a focus on a limited set of prestigious cancer centers. The early launch goal will provide an opportunity to establish reference accounts which will broaden the opportunity to sell to a wider audience. Corvida is collaborating with over 20 leading cancer centers that are participating in the Corvida NCI SBIR Phase II study and are likely to become customers upon completion of the study and receipt of FDA 510(k) clearance.
Management Team
• CEO and President Kent Smith has 30 years of successful global medical device commercialization and business leadership experience, and 10 years of experience in startups. He helped lead a medical device startup from $0 to $30 million with a $310 million acquisition.
• Vice President of Manufacturing Dana Schramm has 20 years of experience in medical device manufacturing, working at companies ranging from $1 million to over $1 billion in sales, and was successful in developing and launching over 50 medical devices.
• Vice President of Research Prasad Sunkara has 35 years of corporate, financing, research, development, and management experience in corporate and startup environments. He has been an officer and/or founder in multiple life science companies, several of which were acquired.
• Co-Founder & CFO John Slump has a BBA in Finance and a background in corporate accounting, fundraising, financial modeling, and capital formation.
• Co-Founder & CTO Jared Garfield has a BBA in Management Information Systems and a background in information technology, engineering, and business management experience.

Company Background

StemMed is a pre-clinical stage drug discovery, development, and testing company that is developing C188-9, a first-in-class, oral inhibitor of signal transducer and activator of transcription (Stat) 3, for treatment of ER-, PR-, HER2- (triple negative) breast cancer (TNBC). StemMed also provides state-of-the-art pre-clinical drug testing services using a panel of 44 breast cancer patient-derived xenograft (PDX) models developed from a diverse patient population, which includes 23 PDX models derived from patients with TNBC; 4 pancreatic cancer PDX models also are available.

Technology Overview 

Stat3 plays a central role in breast cancer stem cell development and has been validated as a drug target in these cells, as well as in the treatment of TNBC, for which no targeted therapy exists. StemMed used computer-based docking to screen 920,000 compounds and identified three small-molecule probes that targeted the phosphotyrosyl peptide-binding pocket within the Src homology 2 domain of Stat3. The most active probe, C188, reduced TNBC PDX tumor volumes and improved tumor-free survival of engrafted mice 4-fold when used in combination with standard chemotherapy. StemMed performed 2-D similarity screening, 3-D pharmacophore analysis, and 3-rounds of structure-activity relationship (SAR)-directed medicinal chemistry to identify C188-9, its lead, first-in-class drug for targeted treatment of TNBC.

Market Potential

The first patients that will be targeted to receive C188-9 will be those patients with locally invasive, metastatic, or treatment-refractory TNBC. An estimated 230,480 new cases of invasive breast cancer were diagnosed in the United States in 2011. Of these, ~40,000 will suffer breast cancer recurrence including 50% of those with TNBC. Unfortunately, standard therapies cannot eradicate the disease and these patients succumb to metastatic disease with a median survival of 2 years. The size of the U.S. market for C188-9 for metastatic/refractory TNBC on a yearly basis is ~20,000 cases for 7 cycles, or a total of 140,000 cycles. C188-9 will be administered orally once daily in the interval between cycles of first-line chemotherapy. Using a conservative figure of $2,000 per cycle, the income generated from 140,000 cycles of C188-9 would be $280 million.

Competitive Advantage

There are two orally bioavailable, small-molecule competitors of C188-9 in development, BP-1-102 and HJC0123. BP-1-102’s modest potency coupled with its low MTD will make it challenging to establish a safe and effective dose of BP-1-102 in humans. HJC0123’s mechanism of action has not been established and the mouse toxicity data presented in the original report was very limited. Other oral agents under development have mechanisms of action that are not understood, substantial toxicity, and did not demonstrate an efficacy signal in Phase I studies.

Financial Overview

StemMed’s drug testing revenue since 2010 totals $913,000. Revenue from STTR grant awards totals $417,000. StemMed also received $100,000 from PDX licensing and $213,000 from partner contributions.

StemMed needs $1 million in external funds for IND-enabling safety and PK studies and for IND filing.

Intellectual Property

StemMed has an exclusive license to ten patents issued to, or filed by, BCM and ownership of composition for C188-9. StemMed also has an exclusive license to use all 48 PDX models for drug testing services, as well as sublicensing to other companies for their in-house use.

Commercialization Strategy

StemMed’s objectives for the next two years are to continue developing its lead product candidate C188-9 by taking it through various studies. StemMed is also in discussions with Atara Biotherapeutics regarding licensing C188-9 for use in cachexia in chronic kidney disease.

Pipeline Products

StemMed has compelling pre-clinical results in cancer cell line xenograft models that also support the use of C188-9 either alone or with radiation therapy in patients with non-small cell lung cancer and head and neck squamous cell cancer. In addition, results from mouse pre-clinical models support its use in patients with cachexia secondary to chronic kidney disease or cancer, and in patients with idiopathic pulmonary fibrosis, scleroderma, inflammatory bowel disease, asthma, and immediate-type hypersensitivity reactions.

Management Team

• President, CEO, and director of drug discovery and development, David Tweardy, MD, discovered key molecular and cellular features of Stat3 during his 28-year research career supported by NIH and other extramural funding totaling over $16 million as PI.
• Vice president and director of drug testing, Michael Lewis, PhD, is an expert in breast cancer biology and developer of 48 breast and pancreatic cancer PDX models whose 15 year research career has been supported by NIH and other extramural funding totaling over $11 million as PI.
• Consultant and vice president of Texas BioAlliance, Jeffrey Larson, PhD, is a drug developer with extensive experience in pharmaceutical, biotechnology, and contract research industries, as well as a record of successful early- and late-stage regulatory meetings with the FDA.
• Consultant and Principal of Soller Regulatory & Research Services, R. William Soller, PhD, has extensive regulatory experience including serving as team leader and lead presenter for over 60 FDA or advisory committee meetings on drug development or postmarketing issues.