Tania Fernandez United States

DreamCatcher Ventures:

Dream Catcher Ventures was founded to address the inefficiencies in the marketplace and to align the goals and aspirations of entrepreneurs with investors. It is focused on creating and building disruptive biotech/healthcare companies that are positioned to excel in global markets.

Currently working with BioHealth Innovation to raise a $50M “Gap Fund” to invest in early stage healthcare businesses, primarily in therapeutics, diagnostics, medtech and healthcare IT.

Founder Profile:

Broad and in-depth experience in both science and business: Over fifteen years of experience in the life sciences and over 10 years of venture investing experience in biotech/ life sciences/healthcare and healthcare delivery with Burrill & Company, a $1.5B life sciences fund.

 Previously on Boards of Adlyfe , a CNS diagnostics company, Strand (A bioinformatics/ genomic data analysis company), White Glove Health, healthcare delivery company (Board observer), Bioimagene, a digital pathology company (Board observer, exited via a  $100M sale to Roche) and the Advisory Board (Finance) for Express Pharma. On the Editorial Board of the "Interdisciplinary Journal of Applied & Biomedical Sciences. Also managed India as a region of investment interest for the firm. Sourced, diligenced and led cross-border investment opportunities in both US and India. Strongly networked to venture capitalists, investment banks, pharma and biotech companies both nationally and internationally.

Mentoring entrepreneurs: Course instructor at UCSF "An idea to IPO and beyond". Involved with business plan evaluations and competitions at Berkeley, UC Davis, LARTA and previously WTC

DreamCatcher Ventures
Founder 

Jorge Ferrer

Technology Name: Intraoperative cancer imaging system

Company Background

The Lumicell Imaging System combines a hand-held, single-cell detection imaging device and a cancer-specific molecular imaging agent (LUM015) for real-time identification of residual cancer in the patient’s tumor bed. The system provides surgeons with visual information to perform a thorough removal of residual cancer cells, thus eliminating the need for repeat surgeries due to positive margins or local recurrence.

Technology Overview

The Lumicell Imaging System is a clinical-stage intraoperative technology for detecting and guiding the removal of all residual cancer during the initial surgery. After the initial breast cancer surgery over 35% of patients undergo a second surgery due to residual cancer.  LUM015, which is injected several hours prior to surgery, emits a fluorescence signal having been activated by cancer enzymes in and around the tumor cells. Lumicell’s imaging head is a hand-held device designed for maneuverability in the tumor bed providing seamless operation within the existing surgical workflow. The system uses Lumicell’s proprietary detection algorithm to highlight regions containing residual cancer in a computer display.

 

Market Potential

Lumicell addresses the unmet need for locating microscopic residual cancer and guiding its removal during the initial surgery. Lumicell is in human clinical trials for breast cancer and sarcoma and have IRB approval to begin trials in esophageal and colon cancers. The U.S. market for Lumicell is a combined $1.43 billion for breast, lung, prostate, colon, esophageal, ovarian, and brain cancers and sarcoma. Most large cancer practices are at risk for the cost of the second surgery and view Lumicell’s product as an immediate financial benefit. The cost savings to the hospitals together with expected additional reimbursement for the guided surgery procedure ensures attractive revenues to Lumicell.

 

Competitive Advantage

A number of devices attempting to detect cancer without an imaging agent have shown poor sensitivity (below 60%) and specificity (below 40%) and struggled to be adopted. Other competitors are developing comparable technology using an imaging agent and device, but Lumicell is far along in the development process having successfully completed a Phase I clinical trial that demonstrates safety and preliminary efficacy (91% sensitivity and 86% specificity). In contrast with competitors’ imaging agents, LUM015 is also specific to cells at the tumor margin, which reduces the dose requirement and increases the signal to background ratio. Unlike the same-day injection of LUM015, some competitors attempting to use antibody-based agents, which take days for clearance, require an extra visit to the clinic by the patient in advance of the surgery. The handheld device, which is insensitive to surgeon’s and patient’s motion, has unprecedented detection of sub-millimeter residual cancer in a large field of view.

Financial Overview

Lumicell is very capital efficient and has raised $6.7 million in Series A and B venture capital funding. Through NSF and NCI SBIR programs, Lumicell has been awarded $2.4 million. The company has also received a $1 million Massachusetts Life Sciences Accelerator Loan, and our academic and clinical collaborators have received about $1.6 million in funding to support pre-clinical and clinical studies with the Lumicell system.

Intellectual Property

Lumicell has obtained an exclusive license from MIT for the use and commercialization of the imaging device. The company also has an expansive IP portfolio (U.S. and international) including specific architectures of imaging agents, methods for labeling the tumor margin, and a novel laser ablation technology for instantaneous and precise removal of residual cancer.

Commercialization Strategy

Lumicell has secured funds to finance operations through the pivotal trial (2015) and expects to raise $10 million upon FDA product marketing approval (PMA) in late 2015 for product launch.

Regulatory strategy and Pipeline Products

Lumicell’s LUM015, combined with our first device, has completed a Phase 1 safety study at Duke University Medical Center. Lumicell’s combination product has been assigned to the device group (CDRH) of the FDA. Lumicell has completed a pre-IDE meeting with the FDA to discuss upcoming trials in breast cancer.  Lumicell aims for FDA approval under a PMA in breast cancer by late 2015. In parallel, Lumicell has developed a laser ablation module to perform precision surgeries required in brain and ovarian cancers. Lumicell has a pipeline of imaging agents offering further benefits including higher signal-to-background ratios, higher specificity for certain types of cancers and at lower doses.

Management Team

  • David Lee, CEO and co-Founder, has 25 years of demonstrated success in product development at Arthur D. Little and has experience running R&D groups and early commercialization of products. He is a co-Founder and the founding CEO of T2 Biosystems, Inc. (NASDAQ:  TTOO) which is about to enter the market.
  • Jorge Ferrer, Ph.D., Director of R&D, developed the original imaging system and LUM015. He has 8 years of experience in research, development, and project management.
  • David Strasfeld, Ph.D., Senior Scientist, trained in physical chemistry, instrument design, and experimentation, leads the device development efforts.

Website:
www.lumicell.com
Lumicell, Inc.
Director R&D 

Dr Greg Fischer

Surgisense Corporation is a privately held C-corporation founded in 2006 with the mission of improving surgical care through intra-operative assessment of a patient’s risk for surgical complications. The company is developing a new category of surgical instruments that integrate a novel oxygen sensing technology which directly measures tissue oxygenation. This enables surgeons to identify patients at risk of surgical complication due to alterations in blood flow and oxygenation through real-time assessment of tissue viability, and propensity to heal.

 

Surgisense’s efforts initially target colorectal cancer for which surgical resection remains the mainstay of treatment. After removal of the tumor, the free ends of bowel are surgically joined to form an anastomosis. Surgisense's Stapled Anastomosis Viability Evaluation (SAVE) System strives to reduce the most dreaded complication: the anastomotic leak; a condition in which fecal material leaks into the abdominal cavity from the surgical junction. The technology integrates into the surgical workflow by replacing the anvil of commercially available, circular staplers with a sensing anvil that wirelessly transmits actionable data to the operative team. The System aims to reduce patient suffering while saving $2 billion annually in excess healthcare costs.

 

Surgisense’s core technology is protected in the largest medical device markets, and is extensible into many clinical applications. The company has been funded through a combination of federal grants and commercial revenue totaling $2.3 million and is looking to raise $6 million in Series A financing to support first-in-human clinical trials, U.S. and E.U. regulatory approval, and product launch.

Surgisense Corporation
CTO 

Mark Forchette

Technology Name:  Ultrasound Tomography for Breast Imaging

Company Background  

Delphinus Medical Technologies, Inc. is a privately held medical technology company headquartered in Plymouth, Michigan and was founded in 2010 as a spin-off of the Barbara Ann Karmanos Cancer Institute (KCI). Delphinus has succeeded in creating an innovative whole breast ultrasound imaging device called SoftVue  that characterizes suspicious lesions for diagnostic applications using a safe (non-ionizing), comfortable (non-compressing), and reliable (operator independent) patented technology.

Technology Overview 

The SoftVue system, designed and manufactured by Delphinus, utilizes ring transducer technology to transmit and receive ultrasound signals, and represents a first-ever innovation in automated whole breast ultrasound.  The unique approach uses a dynamic new design to capture reflection echoes from all directions around the breast and leverages sophisticated algorithms to gather transmitted signals coming through the breast, and image a volumetric map with a single scan…..something no other ultrasound system, currently available, can do. The end result of this approach is enhanced tissue characterization designed to deliver best in class specificity, improved sensitivity and a gentle patient experience.  SoftVue has received 510(k) clearance from the FDA for diagnostic ultrasound imaging and is not a replacement for screening mammography.

Market Potential[ND(3] 

Analysis from Frost & Sullivan in February 2013 reported the global breast imaging market is poised to grow at a CAGR of 15.37% from 2012 reaching approximately $5 billion by 2017. The United States breast imaging systems market research finds that the market earned revenues of $1 billion in 2011 and expects it to reach $1.4 billion by 2016 at a compound annual growth rate of 5.8%. Due to growing legislation and advocacy around the issue of dense breasts and the ineffectiveness of mammography, whole breast ultrasound is gaining traction.  SoftVue represents an innovative new technology and compelling alternative to improve women’s health. The Delphinus business model includes SoftVue systems, consumables and service contracts to hospitals and imaging centers throughout the United States and the rest of the world.

Competitive Advantage

Delphinus is committed to creating improved imaging methods that assist medical professionals better define and diagnose breast disease, while establishing a better patient experience that can be available for all women, regardless of age, and without concern of radiation or discomfort.  SoftVue’s innovative transducer design, with its novel ring configuration, allows through transmission imaging of the whole breast which allows tissue characterization over the entire breast. Furthermore, SoftVue scans the breast quickly (in 1 to 2 minutes) with no additional views required, unlike the other whole breast systems which often require multiple positionings and up to 30-40 minutes per exam. Another competitive advantage is SoftVue’s modular design, which allows the product to be configured easily for different markets and cost level and allows it to grow and evolve in performance by incorporating rapidly improving electronics and computing components.

 

Financial Overview

Delphinus has raised $22.5 million since its inception in 2010 and is launching a process to raise a $35 million series C round to cover the costs of the multi-center clinical trial to support a screening indication, and to support production and commercialization.   Delphinus has no revenue to date.   Potential sources of funding include venture capital firms and/or strategic partners.

Intellectual Property

Delphinus holds or has exclusive license to 14  patents covering broad aspects of its technology. In addition, the company has 12 additional patents pending including narrower aspects of the technology. As a result, Delphinus has broad coverage of the field of use while also covering specific aspects of core technology.

Commercialization Strategy 

The Delphinus business model includes sales of SoftVue systems, consumables and service contracts to hospitals and imaging centers throughout the United States and the rest of the world. The company plans to use a combination of direct and channel sales in the U.S.  For the rest of the world, Delphinus will partner with large distributors and imaging Original Equipment Manufacturers looking for entry into the breast cancer imaging market. Delphinus will produce the devices through subcontracted manufacturing. Final assembly, testing, and quality assurance of the product has been contracted to an FDA and ISO 13485 certified manufacturer located close to the facility in Michigan.

Pipeline Products

Delphinus secured its first 510(k) market clearance from the FDA in December 2013 for Softvue, indicated for use as a B-mode ultrasonic imaging system. The system is not intended to be used as a replacement for screening mammography but it is fully commercially developed for the diagnostic market. The initial clearance established a foundation for future submissions incorporating sound speed and attenuation measurements. Current technical development is aimed at integrating color maps of stiffness tissue with the current imaging capabilities to expand the utility of SoftVue in the diagnostic market.  Plans include additional 510(k) submissions over the next year, initial commercialization outside of the US, and a multi center trial to gain an indication for screening, followed by global commercialization of a system with diagnostic and screening indications.

Management  Team

·         President & CEO, Mark J. Forchette is an accomplished medical technology executive with more than 30 years of demonstrated success driving breakthrough medical technologies to market leadership with companies such as Abbott, OptiMedica, Alcon and Grieshaber.

·         CTO and co-founder, Neb Duric has over 30 years of experience in imaging and is a key inventor of the SoftVue technology.

·         CMO and co-founder, Peter Littrup is a key inventor of the SoftVue technology and a renowned radiologist who has significant experience in breast imaging and has been instrumental in the conduct of ultrasound clinical studies.

·         VP of Engineering, Chris Sanders has over 20 years of global innovation expertise in medical ultrasound and has driven advancements in matrix array transducer design and led collaborative partnerships at companies such as Toshiba and Siemens.

·         VP of Finance, Shawn O’Brien has broad based financial operations experience and has served in senior financial leadership positions at Cyto-Pherex, Kux and Advanced Material Process Corporation.

·         Vice president of Sales and Marketing, Debra Saunders has over 20 years of marketing and sales experience in women’s healthcare with market changing breast cancer detection technologies and has been instrumental in advancing previous medical imaging companies including R2 Technologies, NaviScan, and Lorad.

 
Delphinus Medical Technologies
President/CEO 

Heather Franklin

Blaze Bioscience, Inc. is a privately held biotechnology company focused on the development of guided cancer therapies. Blaze was founded in 2010 and is working to develop Tumor Paint™ products and Optide-based guided cancer therapeutics. Tumor Paint products are designed to provide real-time, high-resolution visualization of cancer cells during surgery, enabling better detection and more complete and precise surgical removal of cancer--while sparing surrounding normal tissue.  Precise illumination of cancer cells has been demonstrated in brain, lung, breast, prostate, colorectal, head and neck cancers and in sarcomas.  The first clinical candidate from the Tumor Paint platform--BLZ-100—is an intravenously (IV) delivered drug that is a combination of a cancer targeting peptide and a fluorescent beacon. The company’s first Phase I clinical study of BLZ-100 is ongoing and initiation of a Phase 1b in brain cancer is anticipated in Q4 2014.   Blaze has an ongoing collaboration with the Fred Hutchinson Cancer Research Center focused on the discovery and development of Optide-based products for use as guided therapeutics.

 

Blaze has licensed patents and patent applications to the Tumor Paint and Optides platforms from the Fred Hutchinson Cancer Research Center and has filed additional patent applications related to Tumor Paint technology and BLZ-100.

 

The company has raised over $20M since 2012 and anticipates initiating a Series C fundraising round in late 2014/early 2015 to support Phase II clinical development of BLZ-100, device development, research Optides guided therapeutics, and other general corporate needs.

Blaze Bioscience, Inc.
President/CEO