Philip Daffas Australia

BCAL Diagnostics is a Sydney, Australia based blood diagnostics company with research facilities based in Kentucky, USA.

The BCAL lipid biomarker test is a universal blood test for the effective screening and monitoring of breast cancer.  The BCAL test is being developed to be safe, cost effective, accurate and available to all women regardless of age, race and geographic location.

BCAL Diagnostics is near completion of a 200-patient study. Initial results indicate the BCAL test has a greater than 90% sensitivity and specificity in the diagnosis of invasive ductal carcinoma which is 85% of all breast cancers. 

This will lead to a range of BCAL breast cancer blood tests that can be used across the full breast cancer disease management continuum. from pre-disposition to screening to long term monitoring.

BCAL Diagnostics is now seeking Series B capital of $5-$10M USD to support its global commercialisation activities.

Year Founded
2010
Biotech Subsector
Medtech Subsector
Medtech Phase of Development
Technology Overview
Breast Cancer Associated Lipids
Alliance & Collaborations
Research agreements with Kentucky University USA and Royal Prince Alfred Hospital - NSW Australia
Supporting Metrics or Evidence
80 patient study completed - 200 patient study near completion
Current Financing Needs
$5-$10M Series B
Current Investors
small number of highly sophisticated investors
IP Status
Strong - patents pending
Recent Milestones
Completed 100 sample study with 90% sensitivity and specificity results for the detection of invasive ductal carcinoma
Management Team Highlights
CEO has global diagnostic experience with Roche Diagnostics, Boehringer Mannheim and Cochlear. Management team has extensive lipids in cancer experience with published papers and PhD
BCAL Diagnostics Pty Ltd
LinkedIn logo CEO 
BIO

 

Phiilip Daffas is the CEO  of BCAL Diagnostics Pty Ltd a Sydney based diagnostics company. With a career spanning more than 25 years, he brings a wealth of experience in global sales, marketing and business development in the medical devices and diagnostics market. 

 Philip has been based in Sydney since 2001 and has held senior global business leadership positions in Europe, US and Australia with blue chip healthcare companies. He has been instrumental in building businesses, growing market share and developing extensive high-level customer and industry relationships in each sector.

 Roles in Australia have included VP Global Marketing at Cochlear and General Management roles with Roche Diagnostics and Bio-Rad Laboratories and CEO of Applied Physiology, an Australian start up company in the intensive care monitoring sector.

Philip’s earlier experience was gained in Europe with market leaders such as IVAC infusion systems and Shiley cardiopulmonary products. He subsequently joined Boehringer Mannheim, initially in the UK managing their diagnostics business and subsequently was promoted to Global Marketing Director for the Diabetes Care business based in Mannheim, Germany.

In 1997 Philip joined Cochlear in the UK as the European Sales and Marketing Manager and subsequently was promoted to the VP Global Marketing role based in Sydney, Australia.

Graduated in the UK with a BSc and Diploma in Electronic Engineering, Philip also holds an MBA and is a Graduate of the Australian Institute of Company Directors (GAICD).


Allan Daisley United States

The majority of medical devices get cleared for commercial deployment through the FDA’s 510(k) clearance process, which is the fastest and most economical route to market for a new medical device. ZeroTo510 has developed a unique program that enables entrepreneurs with ideas for innovative medical devices to take advantage of the fast path to market. ZeroTo510 is a first-of-its-kind cohort-based medical device accelerator. Hosted in Memphis, Tennessee, the program leverages key regional strengths in biomedical research and medical device manufacturing to create a unique program.

Allan Daisley
ZeroTo510 Medical Device Accelerator
LinkedIn logo President 
BIO

Allan Daisley is the director of entrepreneurship and sustainability at Memphis Bioworks Foundation. In this role, he manages entrepreneurship and business incubation programs and helps to grow and support the entrepreneurship ecosystem in the Memphis area. He is the program director of the ZeroTo510 Medical Device Accelerator, an innovative, first-of-its-kind entrepreneurship program that helps entrepreneurs launch new medical device companies, navigate the startup process and deliver their products to market. ZeroTo510 uses a methodology that combines an intensive mentorship-driven, cohort-based program with a seed investment in each company.

 

Allan previously worked as an economic development consultant and managed a business incubator program focused on leveraging entrepreneurship and technology as key drivers of sustainable economic development. He also has spent time in senior strategy and marketing roles at IBM, as a consultant at Accenture, and as an entrepreneur in two start-up ventures. Allan has an MBA from Duke University and a Bachelor of Science in Computer Engineering from the Georgia Institute of Technology.

Ms Natalie Dakers Canada

CDRD Ventures Inc. (CVI) is the commercialization vehicle of the Centre for Drug Research and Development (CDRD), Canada's national drug development and commercialization center that was founded in 2007 and is based in Vancouver, Canada. CVI seeks to advance promising drug development projects from CDRD using internal funds and through partnerships with international pharmaceutical companies, venture capital firms, biotech companies, and other funding agencies. CVI also seeks to in-license technologies from industry or non-CDRD affiliated research institutions. The firm considers both small molecule and biologic innovative technologies in virtually any therapeutic area.

CDRD Ventures
President & CEO 

Barbara Dalton United States

Pfizer Venture Investments (PVI) is the corporate venture capital arm of Pfizer and was founded in 2004. PVI has an annual investments budget of $50 million and invests up to $10M per investing round. The firm focuses mainly on U.S. startups but has global reach. PVI attempts to allocate 80% of its funding to U.S. based companies and utilizes the remaining 20% for international ventures. PVI provides equity funding for private companies in need of seed, growth, or venture financing. Remaining opportunistic, PVI focuses entirely on high growth prospects in all sectors and all phases of development. The ideal candidate has a potential for high growth and returns. Additionally, PVI will seek to in-license products and buyout companies if the opportunity arises.

Pfizer Venture Investments
Vice President 

Jordan Dalton

Norfolk Medical pioneered the oncology market in 1981 by developing one of the first vascular access ports for long-term access.  Since then, we have continued to develop innovative cutting-edge medical devices.  Our latest development is a device for diabetes that allows the body to be insulin independent.  Our device is the world's first active immunoisolation device that facilitates the exchange of oxygen, nutrients, and waste products while protecting against the bodies immune response without the use of additional drugs or immunosuppressant’s.  We are confident that the basic principles of the device can be applied to other applications from anemia and liver failure (NASH) to ALS.  We are currently in the pre-clinical stage of research and are actively looking for a strategic partner to develop this product. 


Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Norfolk Medical Products Inc.
COO 

Patrick Daly

Cohera Medical, Inc.
President and Chief Executive Officer 

Eugene Dariush Daneshvar

Rossellini Scientific

Jane Daun-Tremblay

Shire is an Irish-headquartered global specialty biopharmaceutical company. Originating in the United Kingdom with a large operational base in the United States, its brands and products include Vyvanse, Adderall XR, Intuniv, Lialda, Pentasa, Fosrenol, Replagal, Elaprase, VPRIV, Firazyr and Dermagraft. 

Shire is currently interested in several therapeutic areas for business development opportunities. The company is most interested in the following products: rare disease therapeutics, pre-clinical to on the market; neuroscience therapeutics, on the market; gastrointestinal, on the market; ophthalmology, post proof-of-concept; and hematology; post proof-of-concept.

Shire

Chris Davey Ireland

Marvao Medical is an early stage medical device company founded in 2006 to develop and commercialize products that reduce the incidence of catheter related bloodstream infections. Our first 2 product lines target a $1B global market opportunity. The first product line is now FDA cleared and is being evaluated at 3 centers in the US with very positive results. We are seeking to raise funds in mid/late 2015 to support full commercialization of this product which will enable the company to become highly profitable in early 2017.

 

Year Founded
2006
Medtech Subsector
Indication
Medtech Phase of Development
Technology Overview
We have developed a technology platform that aims to reduce the risk of catheter related bloodstream infections (CRBSI) in patients who require long term vascular access. We have received FDA clearance for our first commercial application of this platform, a hemodialysis (HD) catheter, which is now being clinically evaluated at 3 centres in the US. Our next commercial application is a line of central venous catheters used to deliver chemotherapy, antibiotics, nutrition, and hydration. The overall global opportunity for these two applications is >$1B.
Alliance & Collaborations
In 2008 we entered into a strategic OEM partnership with Harmac Medical Products. Harmac has major manufacturing facilities in the US, Ireland, and Mexico. They have supported our product development programs (including our FDA applications), built our clinical evaluation product, and are now well positioned to rapidly scale up production in 2015.
Supporting Metrics or Evidence
Clinically reported CRBSI rates for HD catheters range between 1.6 and 5.5 events/1000 catheter days. Our HD catheter clinical evaluation has accumulated 3000 catheter days to date with only 1 reported CRBSI event, yielding a rate of 0.3/1000 catheter days. These results have attracted significant interest from healthcare providers who recognise our product's potential to help deliver significantly better care at lower cost within their centers.
Current Financing Needs
Marvao is fully funded to meet our product development and clinical evaluation milestones in 2015. We are looking for new investors to come in alongside our existing investors in Q3 2015 to support our 2016 commercialization program. Our financial model indicates that a quantum of $2.0 - $2.5M is needed to enable the company to become profitable in early 2017.
Current Timeline
In January 2015 we will start the 2nd phase of our clinical evaluation by working directly with one of the world’s two largest HD service providers. The objective is to measure CRBSI rates over 10,000 catheter days across multiple centres in their network. This company is also the market’s single largest purchaser of HD catheters. We expect that low CRBSI rates observed over the course of this evaluation will translate into a significant catheter supply agreement in 2016.
IP Status
Our core technology is currently protected by 4 issued US patents, with 4 additional applications underway. We are in the process of further expanding this portfolio to cover commercially critical product features beyond our core technology.
Recent Milestones
Passed our 2nd FDA QSIT audit in Q3 2014. Passed our annual ISO 13485 certification audit in Q3 2014. Third HD catheter 510k clearance obtained from the FDA in Q4 2014
Management Team Highlights
Eamonn Hobbs: Chairman of the Board. Mark Saab: Co Founder, Principal Investor, Non Executive Director. Chris Davey: Co Founder, CEO
Marvao Medical Devices
CEO 

John Davidson United States

Tangen Biosciences is an early stage diagnostic instrument company that has developed a group of novel technologies that together enable rapid, portable, lab-free, and very low cost molecular diagnostics at the point of care.   

The Tangen platform will amplify and detect specific nucleic acid sequences obtained from a variety of source samples, including clinical specimens such as blood, tissue and sputum, as well as environmental samples obtained from water, soil or food, for example.  The first application of the Tangen platform is the detection and diagnosis of Tuberculosis using DNA extracted from sputum samples, using the Tangen Sputum Processing assay kit

Year Founded
2012
Biotech Subsector
Indication
Biotech Phase of Development
Current Financing Needs

Additional $0.5-1M to close seed round

Tangen Biosciences
CSO