SACRAMENTO, Calif., April 19, 2012 /PRNewswire/ -- SynGen Inc. ("SynGen" or the "Company"), a Regenerative Medicine device company focused on the development of next generation stem cell harvesting systems, announced today that it has completed a $5 million Series A preferred stock financing with Bay City Capital, LLC (BCC). Under the terms of the transaction, BCC will appoint two representatives to SynGen's board of directors.
"We are delighted to have the opportunity to work with Bay City Capital to maximize SynGen's potential. Their expansive knowledge of the global life science field and vast networking capability combined with a strong reputation as a top tier venture capital firm made our decision easy," said Phil Coelho, SynGen's president and CEO. "During the due diligence process, BCC had already begun facilitating business relationships important for our accelerated growth and market expansion."
Mr. Coelho continued, "We will use these proceeds to accelerate the commercialization of our SynGen-1000 platform product (http://syngeninc.com/ProductPipeLine.htm). Initially, we intend to make the SynGen-1000 available to cord blood banks. These banks value the substantially improved cell recovery and high purity of stem and progenitor cells that the product provides, in addition to its ease-of-use, reduced costs and improved data recording standards for automated cGMP cell processing. We expect to file for 510(k) clearance with the FDA and to achieve CE marking for the SynGen-1000 in the near future. Subsequently, our advanced designs target emerging markets including stem cell research centers, hospitals practicing cell therapy in surgical suites and stem cell clinical trials."
William Gerber M.D., investment partner at Bay City Capital, noted, "We expect SynGen's products will play a significant role in enabling clinical research and expanding the medical applications of regenerative medicine. Phil Coelho is an established innovator in the field of cord blood stem cell isolation and purification, and we are excited about expanding SynGen's product line to address novel applications for adult stem cell therapies."
SynGen Inc. enables regenerative cures through innovative engineering. The company invents and commercializes products that utilize single-use sterile plastic cartridge disposables mated to dedicated, highly automated electromechanical medical devices to isolate and capture stem and progenitor cells from peripheral and umbilical cord blood, bone marrow, and adipose tissue. Our products provide an important enabling platform for use in diagnostic, research, and clinical processes. Our inventions are based upon interdisciplinary fields that apply principles of engineering and life sciences to develop solutions required for regenerative medicine. For more information browse syngeninc.com
Bay City Capital is a life sciences venture capital firm investing in opportunities across the various life sciences sectors in companies at all stages of development. Established in 1997, the firm has managed eight venture capital funds representing over $1.6 billion in capital commitments. Bay City Capital has invested in over 90 companies to date and is actively seeking new investment opportunities. Additional information about Bay City Capital can be found at www.baycitycapital.com.
Phone: 916-706-0923 Email: firstname.lastname@example.org
Phil Coelho, president and CEO of SynGen Inc. in midtown Sacramento, is back in the regenerative medicine industry in earnest.
On Wednesday, he announced that his company has received $5 million from San Francisco venture capital firm Bay City Capital LLC to further develop what Coelho calls the next generation in stem cell harvesting systems.
Coelho said the funds will go toward development, marketing and regulatory approval of the company's SynGen-1000 product.
That product harvests stem and progenitor cells from bone marrow, cord blood, normal blood or fat/connective tissue. Harvested cells can be used for treatment of numerous medical conditions.
This is not Coelho's first rodeo in the industry.
He's the founder and former chief executive of Rancho Cordova-based ThermoGenesis Corp., leaving that company's board of directors in 2008.
ThermoGenesis has received international regulatory approvals of its systems for extraction, freezing and archiving of stem cells extracted from blood.
Touting SynGen's "next generation" system, Coelho praised BCC's "expansive knowledge of the global life science field and vast networking capability combined with a strong reputation as a top-tier venture capital firm."
Those factors, Coelho said, "made our decision easy."
Coelho said BCC has "already begun facilitating business relationships important for our accelerated growth and market expansion."
SynGen's immediate goal is making SynGen-1000 available to cord blood banks. Harvesting umbilical cord blood cells is a key component of the stem cell industry.
Coelho, who founded SynGen five years ago, said Wednesday that the company will proceed with the approval process through the U.S. Food and Drug Administration "and regulatory approval overseas."
He called the financing "pure working capital. The initial thing is to get all these regulatory filings and (commence) commercializing before the year is out."
Coelho said prospective segments for SynGen-1000 include "stem cell research centers, hospitals practicing cell therapy in surgical suites and stem cell clinical trials."
BCC, established in 1997, bills itself as a "life sciences venture capital firm investing in opportunities across the various life sciences sectors in companies at all stages of development." It has invested in nearly 100 companies.
Dr. William Gerber, investment partner at BCC, said he expects SynGen systems to "play a significant role in enabling clinical research and expanding the medical applications of regenerative medicine.
"Phil Coelho is an established innovator in the field of cord blood stem cell isolation and purification, and we are excited about expanding SynGen's product line to address novel applications for adult stem cell therapies."
Medical researchers worldwide tout stem cell therapy as a potential game-changer in disease treatments, including bone marrow transplants to treat leukemia.
Some researchers believe harvested cells will someday contribute to groundbreaking treatments of cancer, Parkinson's disease, traumatic spinal cord injuries, amyotrophic lateral sclerosis, multiple sclerosis and various degenerative muscle/nerve disorders.
Under terms of the deal announced Wednesday – involving Series A preferred stock financing – BCC will appoint two representatives to SynGen's board of directors.
More details can be found at www.syngeninc.com.
SACRAMENTO, Calif., April 30, 2012 /PRNewswire/ -- SynGen Inc., a company focused on the development and commercialization of medical systems that harvest stem and progenitor cells, from cord blood, bone marrow, peripheral blood, and other tissues, announced today that it has achieved two key regulatory milestones. The Company was awarded an ISO 13485:2003 Certificate of Registration and a Full Quality Assurance certificate by the British Standards Institution (BSI), which allows it to CE Mark its own Class 1 products.
ISO 13485:2003 is an internationally recognized standardization system for the design, development, manufacturing and distribution of medical devices. The certification confirms that SynGen has successfully implemented a quality system that conforms to the exacting standards of the International Organization for Standardization (ISO) standards for medical devices.
SynGen also received CE Mark from BSI that allows SynGen to begin marketing its SynGenX -1000 Platform devices for the processing of cord blood in the European Union (EU). A CE Marking is a European marking of conformity that indicates a product complies with the essential requirements of the applicable European laws or directives with respect to safety, health, environment and consumer protection. The CE Marking is required on products in the countries of the European Economic Area (EEA) to facilitate trade among the member countries. The CE Marking provides a means for a manufacturer to demonstrate that a product complies with a common set of laws required by all of the countries in the EEA to allow free movement of trade within the EEA countries.
In addition to ISO Certification and CE Mark milestones, SynGen has also filed a 510(k) submission with the FDA for the clearance of the SynGenXTM-1000 platform products to process cord blood for the US marketplace, and that submission is pending with the FDA. These products harvest and cryogenically freeze stem and progenitor cells from collected units of placental/umbilical cord blood. These cells may be used later to reconstitute the hematopoietic system of patients afflicted with hematologic malignancies, like leukemia and lymphoma, and more than 70 genetic diseases.
Philip Coelho, SynGen's CEO noted that "We are very proud and excited about our achievement of these two key regulatory milestones, ISO 13485:2003 and CE mark certification. This accomplishment required the total dedication of every employee in the company but I especially want to praise Dr. Prince Emmanuel, our Vice President of Research & Development whose leadership and dedication to capturing every detail made it possible. Shaping our business practices to remain in full compliance with these regulations will demonstrate SynGen's dedication to continuously improve product quality by providing finished medical devices that consistently meet and exceed customer and regulatory requirements. This quality and regulatory milestone demonstrates that the systems and processes we have implemented at SynGen are effective to take this unique technology through product development and manufacturing into the marketplace."