Launch Expands Natera's Leadership Position in Women's Reproductive Health
SAN CARLOS, Calif., March 1, 2017 /PRNewswire/ —Natera (NASDAQ: NTRA), a leader in genetic testing, today announced the upcoming launch of Evercord; a new offering being made commercially available in the second quarter of 2017 that enables expectant parents to collect, store and potentially retrieve their newborn's cord blood and tissue for therapeutic use in transplantation and regenerative medicine applications. Natera aspires to build a different type of national cord blood company, by combining best-in-class cord blood cryopreservation with the company's ability to provide timely information about genetic disease risk; potentially expanding families' stem cell treatment options in the future. Natera will offer Evercord through its leading direct sales channel in the United States.
The Market Potential of Cord Blood Stem Cells
Newborn stem cells sourced from umbilical cord blood are known to contain hematopoietic stem cells (HSCs) that can potentially differentiate and regenerate healthy blood and immune systems. Unfortunately, out of the roughly four million births each year in the United States, more than 95% of the cord blood from those births is currently discarded as waste;1 highlighting a significant opportunity both for families who could benefit from cord blood, and for Natera, as it enters the cord blood and tissue banking market. Published data also suggests that one in three people in the United States, or 128 million people, could potentially benefit from regenerative medicine applications which, if proven effective, expands the possible therapeutic use of cord blood stem cells.2 More than 300 studies are currently underway, including clinical trials focused on current and new cord blood stem cell therapies in regenerative medicine.3 These trials hold promise for a growing list of conditions, including Alzheimers disease, cerebral palsy, diabetes (Type I/II), spinal cord injury, cartilage and bone repair, and heart defects. More than 30,000 cord blood stem cell treatments have been conducted worldwide and Natera's prenatal tests, including its carrier test, Horizon™, currently screen for 35 of the nearly 80 diseases where cord blood stem cell treatment has been administered. Considering the research advances in stem cells and regenerative medicine, it is anticipated that number will, more than likely, continue to grow.
The launch of Evercord is part of a partnership with Bloodworks Northwest, one of the oldest and most reputable public umbilical cord blood banks in the country. Evercord's service will offer expectant families the opportunity to bank their baby's umbilical cord blood and tissue for potential medical use by the child or related family member. Under the terms of the agreement between Natera and Bloodworks, Bloodworks will perform processing and testing services on cord blood samples submitted by Evercord customers and will cryo-preserve the banked cord blood and tissue at its Seattle, Washington-based best-in-class cord blood cryopreservation storage facility. The companies also plan to build a new facility in anticipation of future growth.
The relationship offers several other competitive advantages. Evercord leverages Bloodworks' 20 years of experience processing and banking cord blood; the lab has a strong track record of successfully releasing nearly 1,000 cord blood samples for transplant, more than other leading private cord blood banks.
Once Evercord is commercially launched, it will expand Natera's existing portfolio of women's reproductive health products, further diversifying Natera's revenue base and adding a traditionally high yield business into its product mix. Evercord will also be well positioned to immediately take advantage of Natera's well-established commercial capabilities, including: patient and healthcare provider digital services through Natera's Patient Portal and Natera Connect, and a specialized salesforce that already calls on the nation's busiest obstetrics and gynecology offices and fertility centers.
"At Natera, we believe adding cord blood and tissue banking to our product offerings is a natural extension of our commitment to family health and beyond," said Matt Rabinowitz, CEO and founder of Natera. "Evercord builds on our excellence as a genetic testing company and our mission to transform the diagnosis and management of genetic diseases. Cord blood stem cells have demonstrated regenerative capabilities that medicine is just beginning to learn how to harness; offering a unique opportunity to potentially generate complete genetic information on a human being at the moment of birth. Many of the genetic diseases that cord blood treats today are also conditions that our tests screen for, which could enable us to offer a far more extensive service offering in the future than those offered by leading 'storage-only' cord blood banks today."
About Bloodworks Northwest's Public Cord Blood Program
Bloodworks Northwest partners with hospitals across the region to recover and store umbilical cord blood from new mothers — an important source of stem cells for use in cancer treatment, metabolic or immune system disorders, and research. Bloodworks Northwest created the first and only public umbilical cord blood bank in the Northwest of the United States and has program partnerships with 15 hospitals across Washington, Oregon and Hawaii – providing nearly 50 units per month to the national cord blood registry.
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system.
Product offerings include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier test to detect inherited mutations; the Panorama® non-invasive prenatal test (NIPT) to identify common chromosomal anomalies in a fetus as early as nine weeks of gestation; and Evercord™, a cord blood and tissue banking service offered at birth to expectant parents.
Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test.
These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release.
Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, whether cord blood or cord tissue will be found to be effective in treating additional conditions, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers.
Additional risks and uncertainties are discussed in greater detail in the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Natera's Form 10-Q for the quarter ended September 30, 2016. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company's website at www.natera.com under the Investor Relations section, and on the SEC's website at www.sec.gov.
1 https://parentsguidecordblood.org/en/cord-blood-infographic (February 2017).
2 Harris, D., & Rogers, I. (2007). Umbilical Cord Blood: A Unique Source of Pluripotent Stem Cells for Regenerative Medicine. Current Stem Cell Research & Therapy,2(4), 301-309. doi:10.2174/157488807782793790; http://www.mdpi.com/2227-9059/2/1/50/htm
3 https://clinicaltrials.gov/ct2/results?term=Umbilical+AND+Stem+Cells (February 2017).