Company

News

2016


System Introduction at the Association of Molecular Pathology (AMP) 2016 Annual Meeting

IRVINE, Calif., Nov. 30, 2016 -- WaveSense, Inc. (www.wavesense.com) the leader in targeted cell isolation and enrichment, announced today the introduction of the nRichDX system for the bulk isolation of target cells and nucleic acids from liquid biopsies. The nRichDX utilizes WaveSense’s proprietary paramagnetic bead technology to enable the capture of circulating tumor cells (CTCs) and cell free DNA or RNA (cfDNA or cfRNA) in quantities sufficient for analysis by Next Generation Sequencing (NGS) and PCR techniques. The system can capture cells and nucleic acids from an array of sample types including blood, urine and bone marrow and is specifically designed and optimized for high volume, low yield specimens. The nRichDX system is positioned to complement the company’s already successful EpiSep® direct-to-slide enrichment technology that services the cytogenetic (FISH) market.

The use of liquid biopsies in molecular diagnostics has become an integral part of the diagnosis and treatment of disease. With this, the use of NGS and PCR is now standard practice in the downstream analysis of nucleic acids in both clinical and pharmaceutical laboratories. The WaveSense nRichDX enrichment system is a powerful liquid biopsy tool that ensures the optimal isolation of the correct cell types in quantities sufficient for molecular analysis.

"The continued development of liquid biopsy will make significant and important changes in the diagnostic paradigms of cancer patients as well as in the approval of new chemotherapeutics," said WaveSense CEO William Curtis, "The nRichDX system is well positioned to become the industry standard for the delivery of specific target cell populations and nucleic acids for downstream analysis via NGS, PCR and other molecular platforms."


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. The WaveSense In Vitro diagnostic (IVD) product line provides the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufactures the only FDA-listed IVD and CE-IVD products for paramagnetic coupled antibody targeted cell enrichment in the US and EU.

For more information, visit www.wavesense.com or email: info@wavesense.com


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IRVINE, Calif., Sept. 27, 2016 -- WaveSense, Inc. (www.wavesense.com) the leader in targeted cell isolation and enrichment from liquid biopsies, announced today that it has signed a new strategic marketing relationship with Pisces Scientific Ltd., a leading independent diagnostics distributor in the United Kingdom (UK) and Ireland. Pisces was founded and continues to be dedicated to the importation and distribution of innovative products and instruments for in vitro diagnostic and research labs focusing on cytogenetics, molecular genetics, and molecular pathology. Pisces Scientific will now market and sell the WaveSense CE-IVD marked cell enrichment platform, a growing pipeline of cell enrichment products. Current CE-IVD products include the EpiSep®, direct to slide enrichment technology, as well as their proprietary paramagnetic bead technology for the selective isolation of cells expressing CD138.

William Curtis, WaveSense CEO, said that "Pisces Scientific has established itself as a trusted distribution partner due to their strong relationships with many of the country’s leading hospital and academic research laboratories." He added, "We look forward to working with Pisces Scientific and building on the synergy of this partnership. We will work together to meet the growing demands for selective cell enrichment for customers in the UK and Ireland."

Pisces Scientific Managing Director, Stewart Kennedy, added "As molecular diagnostics become an integral part of the diagnosis and treatment of cancer there is growing concern that the correct cell type is being evaluated. The WaveSense technology directly addresses this concern, and with this partnership, we will now be able to deliver the optimal solution to cytogenetic laboratories within the UK and Ireland."


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. The WaveSense In Vitro diagnostic (IVD) product line provides the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufactures the only CE-IVD products for paramagnetic coupled antibody targeted cell enrichment.

For more information, visit www.wavesense.com or email: info@wavesense.com


About Pisces Scientific Ltd.

For over two decades Pisces Scientific has offered high-level expertise in distribution strategies and is dedicated to provide innovative solutions to all laboratory needs in the fields of cytogenetics, molecular genetics, and molecular pathology. Headquartered west of Edinburgh, Pisces is in close proximity to a number of large Universities and Research Hospitals, thus enabling many valuable scientific collaborations. Pisces Scientific currently represents many major international leaders in genetic imaging, as well as provides innovative DNA screening solutions for fast and accurate detection of human genetic diseases in cytogenetics and cancer. Pisces Scientific is positioned as a valuable partner in prenatal, constitutional and hematology-oncology cytogenetics. They are committed to dedicated customer service by providing high quality technical support and continually seeking ways to offer more powerful and complete solutions to our customers. Currently serving the UK and Ireland, Pisces Scientific’s objective is to be a primary supplier of research and diagnostic products for Molecular Biology and Cytogenetics Laboratories throughout Europe.

For more information, visit www.piscesscientific.com or email: info@piscesscientific.com


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IRVINE, Calif., Sept. 21, 2016 -- WaveSense, Inc. (www.wavesense.com) the leader in targeted cell isolation and enrichment from liquid biopsies, announced today that it has received CE-IVD marking approval for their suite of cell isolation and enrichment technologies. The approval includes the EpiSep® direct to slide enrichment technology as well as their proprietary paramagnetic bead technology for the selective isolation of cells expressing CD138. CE marking allows for marketing and sales of the products in the European Union and other countries. The WaveSense system, a growing pipeline of cell enrichment products, can be used for selective recovery/enrichment of cells expressing the CD138 cell surface antigen in biological fluids and tissue culture.

As molecular diagnostics become an integral part of the diagnosis and treatment of cancer there is growing concern that the correct cell type is being evaluated. This concern is most acute when a negative result is reported. The WaveSense cell enrichment platform is designed to address this issue and is in routine clinical use for multiple liquid biopsy applications, including one for the isolation and capture of positive CD138 cells. This is critical for identifying genomic and proteomic abnormalities in plasma cell neoplasms. A cell enrichment study led by Gary Lu, M.D., Department of Hematopathology, the University of Texas MD Anderson Cancer Center, showed that the median plasma cell percentage in non-enriched bone marrow specimens increased from 8% to 73% in enriched bone marrow specimens, implying a 9-fold increase in diagnostic sensitivity. (Arch Pathol Lab Med—Vol 137, May 2013).

"CE marking approval for the WaveSense product line, a FDA Class I technology, represents a significant milestone and accomplishment by all of the employees of WaveSense," said CEO William Curtis, "The completion of the registration signifies that we are complying with the high standards of the EU governing authorities in the areas of quality, safety and performance."

"The CD138 isolation and enrichment product for bone marrow is the company’s immediate commercialization focus in the EU," added Curtis, who noted that the product is already in use by a growing number of prominent reference laboratories and cancer centers in the US and WaveSense can now replicate this acceptance in many European countries.


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. The WaveSense In Vitro diagnostic (IVD) product line provides the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufactures the only CE-IVD products for paramagnetic coupled antibody targeted cell enrichment.

For more information email info@wavesense.com


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IRVINE, Calif., Mar. 1, 2016 -- WaveSense, Inc. (www.wavesense.com) the leader in targeted cell isolation and enrichment from liquid biopsies, is proud to unveil new corporate branding elements including a new tagline and website redesign. The website has been completely revamped to reflect its updated brand image and to provide a better user experience.

"Our new identity further distinguishes us in the marketplace and enhances our position as the leader in targeted cell isolation and enrichment. The new website allows users to gain a better understanding of WaveSense and truly showcases who we are as an organization and what we stand for.” – said Angela Shelley, Marketing Manager.

The WaveSense website will be updated on a regular basis to introduce and support the multiple new product applications that are scheduled for release during 2016.


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. WaveSense’s In Vitro diagnostic (IVD) products provide the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufacturers the only IVD products for paramagnetic coupled antibody targeted cell enrichment.


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Fast Growing Liquid Biopsy Company Strengthens Resources

IRVINE, Calif., Mar. 1, 2016 -- WaveSense, Inc. (www.wavesense.com) the leader in targeted cell isolation and enrichment from liquid biopsies, announced today that Alex Wolfe has joined the firm to further develop their growing portfolio of regional and national accounts. Alex Wolfe comes with a wealth of experience within the laboratory industry, having spent 7 years as a cytogenetic technologist and the last 3 years at Applied Spectral Imaging where Alex was instrumental in developing numerous customer relationships. His arrival coincides with the launch of WaveSense’s expanded suite of liquid biopsy-based hematopathology applications, including CD138+, CD34+ and CD19+.

Alex joins WaveSense as National Accounts Manager to continue WaveSense’s recent success providing the most sensitive, effective and efficient cell isolation and enrichment technology to a growing number of the top cancer centers, medical institutions and reference laboratories. Alex commented “I am excited to start a new challenge within WaveSense and look forward to working with the team to further develop their growing suite of liquid biopsy applications. I am fortunate to be joining a company whose cell isolation/enrichment products are on the verge of becoming the industry-standard.”

Peter Hartmayer, Executive Vice President of Sales, said "Alex’s wealth of experience and industry knowledge has already made him a key addition to the WaveSense family. We view his appointment as a sign of our commitment to being the leading company in our industry. Our new innovations and the increasing demand from our customers led us to look for an addition to our team who will fit in with our ethos of innovation and exceptional service, and it is very fortunate that we were able to find someone of Alex’s caliber to fulfill this role. I’m confident that Alex will play a key role in providing and implementing high quality solutions for our clients."


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. WaveSense’s In Vitro diagnostic (IVD) products provide the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufacturers the only IVD products for paramagnetic coupled antibody targeted cell enrichment.


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2015


Fast Growing Liquid Biopsy Company Strengthens Resources

IRVINE, Calif., Nov. 16, 2015 -- WaveSense, Inc. (www.wavesense.com) the leader in targeted cell isolation and enrichment from liquid biopsies, announced today that Chris Williams has joined the firm as Vice President of Business Development. Chris comes to WaveSense with more than 25 years of experience in both pharmaceutical and diagnostics industries. Chris’ past experience includes roles at Millennium Pharmaceuticals, PerkinElmer and most recently SkylineDx. In his role he will work with industry leaders to expand the current WaveSense product portfolio, establish key relationships with opinion leaders, and work closely with sales and marketing to drive sales and establish the company brand.

Chris joins WaveSense to provide and build upon recent successes in providing cell isolation and enrichment technology to a growing number of the top cancer centers, medical institutions and reference laboratories. Chris commented "I look forward to working with the great people at WaveSense to provide the best possible products for cell isolation and enrichment to the diagnostic industry."

Bill Curtis, Chief Executive Officer, said "Chris’ wealth of experience and industry knowledge has already made him a key addition to the WaveSense family. His appointment underscores our commitment to being the leading company in our industry. Our new innovations and the increasing demand from our customers led us to look for an addition to our team who will fit in with our ethos of innovation and exceptional service. It is very fortunate that we were able to find someone of Chris’ caliber to fulfill this role."


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. WaveSense’s In Vitro diagnostic (IVD) products provide the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufacturers the only IVD products for paramagnetic coupled antibody targeted cell enrichment.


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IRVINE, Calif., Sept. 10, 2015 /PRNewswire/ -- WaveSense has named two veteran health care executives to top leadership positions and received a multi-million dollar capital investment to drive the company's growth. WaveSense is the developer of the only FDA-registered in vitro diagnostic (IVD) devices for targeted cell isolation and enrichment. The sensitivity of this patented platform technology enables major cancer centers, laboratories, diagnostic equipment manufacturers and pharmaceutical companies worldwide to achieve significantly more reliable and accurate diagnostic results.

WaveSense has welcomed Jack L. McGinley as its new chairman. Prior to co-founding RoundTable Healthcare Partners in 2001, McGinley spent 30 years in senior management at Baxter International, departing as executive vice president. In addition, William W. Curtis was appointed chief executive officer to develop and implement the company's new strategic commercialization plan. Curtis has been a health care executive since 1983, including as co-founder and chief executive officer of CBLPath Holdings, Inc. WaveSense co-founder Christopher Feistel continues as chief technology officer, responsible for leading innovation and expansion of the WaveSense portfolio of liquid biopsy and molecular diagnostic tools.

As molecular diagnostics become an integral part of the diagnosis and treatment of cancer there is growing concern that the correct cell type is being evaluated. This concern is most acute when a negative result is reported. The WaveSense cell enrichment platform is designed to address this issue and is routinely in clinical use for multiple liquid biopsy applications, including one for the isolation and capture of positive CD138 cells. This is critical for identifying genomic and proteomic abnormalities in plasma cell neoplasms. A cell enrichment study led by Gary Lu, M.D., Department of Hematopathology, the University of Texas MD Anderson Cancer Center, showed that the median plasma cell percentage in nonenriched bone marrow specimens increased from 8% to 73% in enriched bone marrow specimens, implying a 9 fold increase in diagnostic sensitivity. (Arch Pathol Lab Med—Vol 137, May 2013).

"The sensitivity and specificity of the WaveSense CD138 enrichment technology enables cell isolation from either bone marrow or peripheral blood specimens," said Curtis. "This specimen flexibility allows clinicians to diagnose and monitor patients less invasively for minimal residual disease (MRD) and also opens up new doors for other plasma cell neoplasms, such as MGUS and smoldering multiple myeloma (SMM), conditions best defined as pre-multiple myeloma."

The CD138 isolation and enrichment product for bone marrow is the company's immediate commercialization focus, added Curtis, who noted that the product is already in use by a growing number of prominent reference laboratories and cancer centers, including an NCI-designated cancer center.


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. WaveSense's in vitro diagnostic (IVD) products provide the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufacturers the only IVD products for paramagnetic coupled antibody targeted cell enrichment.


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IRVINE, Calif., Aug. 31, 2015 -- WaveSense, Inc. (www.wavesense.com) announced today that Kim Aminpour and Angela Shelley have joined the rapidly growing liquid biopsy company.

Kim joins WaveSense as Sales Administrator responsible for managing the development of the expanding Sales department at the Irvine facility. Kim says, "I’m excited to participate in the evolution of the sales department with a focus on developing the processes and tools necessary to better serve our clients."

Kim comes with a wealth of experience in the sales and marketing arena and has spent over 25 years in contract and proposal management, sales, marketing, operations, as well as human resources, technical support and manufacturing. She has gained extensive experience at high-tech companies such as Boeing Commercial Aerospace, Gulfstream Aerospace, Jet Propulsion Laboratory and Toshiba America in Irvine, CA.

Angela, an experienced marketing professional, joins WaveSense as Marketing Manager. Her responsibilities include developing, planning and implementing all key marketing initiatives, including the further development of the WaveSense brand.

Angela commented, "I am proud to be joining the WaveSense team. It is an organization that believes in its products and its people and is fully committed to enabling superior outcomes for the clinicians, researchers and the patients benefiting from the WaveSense technology. It is hard to find an organization with so much passion and, as a passion-driven person, I feel this is the right fit for me".

Angela brings over 10 years’ experience working directly with international and domestic companies on brand development, marketing initiatives, and strategies - - taking their products and services to successful new levels by enhancing brand image and developing client-focused marketing campaigns.


About WaveSense

WaveSense, based in Irvine, CA (www.wavesense.com) is the leader in targeted cell isolation and enrichment from liquid biopsies. WaveSense's in vitro diagnostic (IVD) products provide the most sensitive targeted cell enrichment solution, requiring only a small specimen to deliver the maximum number of pure target cells while simultaneously eliminating background cells. Without the need for expensive capital equipment, WaveSense technology enables enhanced patient diagnostic and management outcomes by optimizing the results of downstream diagnostic modalities including IHC, FISH, PCR, SNP, Gene Expression and NGS. The WaveSense platform fulfills the need to improve workflow, test sensitivity and test results while increasing revenue and reducing operational costs and complexity. WaveSense manufacturers the only IVD products for paramagnetic coupled antibody targeted cell enrichment.


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Contact Us

Our Corporate Office
15339 Barranca Parkway
Irvine, CA 92618

Phone: 949.341.1980
Fax: 949.341.1982

Email: info@wavesense.com