KIYATEC

  • Sam Patrick posted an article
    KIYATEC and OHSU initiate patient enrollment into key oncology clinical trial. see more

    GREENVILLE, S.C.-- KIYATEC, Inc., today announced that Oregon Health & Science University (OHSU) Knight Cancer Institute has initiated patient enrollment into KIYATEC’s clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies for solid tumors.

    In this clinical study, the test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether or not those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors.

    At present, the OHSU Knight Cancer Institute is enrolling newly diagnosed and relapsed ovarian cancer patients into the 3D-PREDICT Study.

    “As a pioneer in personalized cancer care, the OHSU Knight Cancer Institute is deeply committed to optimizing appropriate therapy for our patients as early as possible following diagnosis, when the disease is most treatable,” said Dr. Koen De Geest, lead investigator of the clinical trial at OHSU. “Five-year survival among high-grade ovarian cancer patients is 30%, and we believe this test has the potential to help improve outcomes in the clinic.”

    “With cancer treatment, and especially ovarian cancer, time is of the essence and being able to measure patient-specific evidence of response and non-response before treatment begins can truly change the future of cancer care,” said Matthew Gevaert, CEO of KIYATEC. “We welcome OHSU to our clinical study and their participation will be integral as we work to deliver accurate predictions of patient response to cancer therapies, reducing the need for patients to undergo treatments that may not work.”

    The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on https://clinicaltrials.gov/ct2/show/NCT03561207.

    About KIYATEC, Inc.
    KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to therapies before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to 
    accurately predict treatment response prior to beginning treatment.

  • Sam Patrick posted an article
    Study to investigate potential impact to outcomes for several difficult-to-treat solid tumors see more

    3D-PREDICT Study to investigate potential impact to outcomes for several difficult-to-treat solid tumors

     

    GREENVILLE, SC. – June 20, 2018 – KIYATEC, Inc. today announced the enrollment of the first patients in a U.S. clinical study of its Ex Vivo 3D drug response assay (EV3D™) across several difficult-to-treat solid tumors. The 3D-PREDICT clinical study has been initiated at the Cancer Institute of Greenville Health System (GHS) with the goal of recruiting 640 patients across additional clinical sites to be added in the future.

    The 3D-PREDICT Study is a prospective, open-label, multi-institutional, non-interventional study to validate the EV3D assay for clinical use and to investigate the impact on outcomes for cancer patients with both newly diagnosed and recurrent epithelial ovarian cancer and recurrent high-grade gliomas, which include glioblastomas (GBM). Over the next year or so, the study will expand to include patients with newly diagnosed high-grade gliomas, high-grade rare tumors and triple negative breast cancer. The primary objectives of the study are to establish correlation between assay predicted drug response and patient clinical outcomes, and to measure the potential impact of the assay on therapeutic decision-making. The study is anticipated to continue through 2022. Details on the trial can be found on ClinicalTrials.gov

    The EV3D assay platform assesses a patient’s own cancer cells within a biologically relevant 3D culture microenvironment to provide individualized response prediction to specific therapeutic agents. In this study, the therapeutic agents predicted consist of available, guideline recommended drug options for each cancer type. 

    “As an institution, we’ve supported KIYATEC’s pilot clinical studies by providing over 450 samples of cancer tissues spanning the multiple tumor types they are testing and our clinical investigators are ready to take this important next step,” said Larry Gluck, MD, Medical Director of the GHS Cancer Institute. “Patients with recurrent ovarian cancer and recurrent GBM are among those with the most challenging prognosis at every cancer center around the country. The fact that KIYATEC is offering us a new tool in these very difficult to treat populations is a needle mover for these patients coming to Greenville for their treatment.”

    Patients with these kinds of newly diagnosed and recurrent cancers simply do not have the luxury of time on their side. Their time, health and money spent on a treatment that is not working can have devastating consequences that we all want to avoid,” said Matthew Gevaert, CEO of KIYATEC. “The commencement of this clinical trial builds upon the success of our pilot studies and represents a significant milestone toward our goal of helping cancer patients receive the best treatment at the earliest possible time.”


    About KIYATEC, Inc.

    KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to chemotherapy drugs before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to accurately predict treatment response prior to beginning treatment.

     

    About Greenville Health System

    Greenville-based Greenville Health System (GHS) has partnered with Columbia-based Palmetto Health to form a not-for-profit health care delivery system serving 1.2 million patients annually across South Carolina. The new name and graphic identity are expected to be announced later this year. GHS offers patients an innovative network of clinical integration, expertise and technologies through its academic health system, eight medical campuses, tertiary medical center, research and education facilities, community hospitals, physician practices and numerous specialty services. GHS, by itself a 1,627-bed system, is home to 16 medical residency and fellowship programs, as well as partnership efforts such as the University of South Carolina School of Medicine Greenville and the soon-opening Clemson University Center for Nursing, Health Innovation and Research. Visit www.ghs.org for more information.

  • Sam Patrick posted an article
    KIYATEC growth supports upcoming programs to better predict patient response to oncology drugs see more

    GREENVILLE, SC. – May 29, 2018 – KIYATEC, Inc., a privately held company changing the future of cancer care by predicting patient response to oncology drugs prior to treatment, today announced an expansion of its leadership team with the appointment of two industry veterans. Charlene Knape has joined the company as Vice President of Clinical Affairs, and Timothy Decker as Vice President Commercial Operations.

    Mr. Decker, a twenty year industry leader with a proven track record of developing and commercializing oncology diagnostic services and pharmaceuticals, has assumed responsibility for pre-launch commercial strategic development along with tactical planning and execution to drive clinical product launches. Mr. Decker held roles of increasing responsibility in strategic and tactical marketing for a decade at G.D. Searle and Abbott Laboratories before joining Genomic Health, Inc.  Over an eight year span, he played a lead role as Director and Senior Director in the global launch, marketing, reimbursement and sales of Oncotype DX molecular diagnostic tests in breast, colon and prostate cancers. Mr. Decker subsequently served as Vice President of Marketing at Castle Biosciences, Inc., where he drove corporate and pipeline strategy, as well as in-line product strategy and revenue growth for its molecular diagnostic tests in melanoma. He joins the company from Mexico City-based Grupo Fármacos Especializados, where he served as Division Head, Oncology Diagnostics, responsible for developing reimbursement pathways and securing positive coverage decisions among public and private sector payers.

    With more than 25 years of experience working with diagnostic companies, Ms. Knape is responsible for leading the clinical development programs and clinical operations for KIYATEC’s pipeline for ovarian cancer, glioblastoma, rare tumors and triple negative breast cancer. She most recently served as Senior Director, Clinical Development for Inivata, a clinical cancer genomics company utilizing liquid biopsies for comprehensive genomic profiling of tumors. Prior to this, Ms. Knape served in Becton Dickinson’s Corporate Clinical Development group, responsible for global clinical quality and contracts. Ms. Knape spent five years with Micell Technologies as Senior Director of Clinical Affairs where she managed all global clinical activities for first-in-human and CE Marking studies for an implantable cardiovascular device from initiation through successful regulatory submission. As the company’s lead in clinical operations, Ms. Knape also built the team and initiated a 1,400-patient study in Europe and a 400-patient study in China. Previously, Ms. Knape served as Vice President, Clinical Affairs at EndoTex Interventional Systems, led the clinical functions for Avocet Medical and Somnus Medical Technologies and held clinical affairs positions in the Companion Diagnostics and Biorepository at LabCorp.

    “At this pivotal time in the company’s growth, we are thrilled to welcome Charlene and Tim to KIYATEC. These two newly created positions are critical as we expand our clinical programs in key therapeutic areas and further strengthen our plan for the broad adoption of our patient-specific response prediction tests,” said Dr. Matthew Gevaert, CEO of KIYATEC. “Their expertise and industry knowledge is unparalleled and they will be instrumental as KIYATEC continues toward its path of changing the future of cancer care by predicting patient response to chemotherapy before treatment begins. I’m so glad to have Tim and Charlene on our team as we move toward our goal of commercialization and helping patients receive optimal treatment at the earliest possible time.”

    KIYATEC will be attending the American Society of Clinical Oncology (ASCO) meeting being held June 1-5 in Chicago.

    About KIYATEC, Inc.

    KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to chemotherapy drugs before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to accurately predict treatment response prior to beginning treatment.

  • Sam Patrick posted an article
    Leading-edge innovators, top presenters headed for SEMDA's Medtech 2018 in South Carolina see more

    Leading-edge innovators present for recognition, reward at annual gathering of Southeastern who’s who in medical technology, devices and diagnostics


    Greenville, SC – April 27, 2018 – At least 23 organizations ranging from start-ups to well-established companies have been accepted to present their latest, ground-breaking innovations to entrepreneurs, innovators, angel investors and business leaders from across the life sciences space as the Southeastern Medical Device Association (SEMDA) 2018 Medtech Conference convenes in Greenville, SC May 2-4, 2018.  

    SEMDA -- a non-profit trade association focused on making the Southeast a world-class region for medical technology, device, and diagnostic companies – has invited 23 finalist companies to present at PitchRounds 2018 – a highly targeted venue for both “Seed” companies as well as later-stage organizations to present innovative ideas to panels of institutional investors, regulatory leaders, venture capital directors, IP experts and others.

    Companies from seven Southeastern states will present ground-breaking ideas and technologies to hundreds of industry leaders.  Host state South Carolina leads the way with 10 companies invited to present, followed by Georgia and Florida with three companies each.  North Carolina, Alabama, Virginia and Tennessee are also represented.

    Among the South Carolina companies invited to present are Zylo Therapeutics, Accessible Diagnostics, KIYATEC and Moterum from host city Greenville, while Charleston’s Sanguine Technologies and Cryogenix, and Columbia’s Proof Biotechnologies are also invited.

    Invitees from Georgia include Intent Solutions and nfant, both of Atlanta, while North Carolina entries include Diamond Othopedic of CharlotteMemphis, Tennessee’s Sweetbio, Birmingham’s Circulogene and Nashville’s Raiven are also featured invitees.

    Twelve Early-stage companies from the Carolinas, Alabama and Florida have been invited to present at PitchRounds, with four finalists to be selected to compete for $10,000 in prize money, while getting to meet investors and partners at sessions and networking receptions.  SCBIO, SCRA and global law firm Eversheds Sutherland are co-sponsors of PitchRounds.

    Among the featured speakers committed to present at the conference are keynoter Joe Lee, Executive Director of Life Sciences for JP Morgan; Andy Fish, Chief Strategy Officer of AdvaMed; and Denise Hines, North American Chair of the Health Information & Management Systems Society and current CEO of eHealth Services Group.   

    Joe Lee is Executive Director of Life Sciences for JP Morgan and leads the Middle Market Banking coverage of life science companies across the Southeast. Widely respected in life science industry circles, Mr. Lee will discuss key opportunity areas for growth in the Southeast and provide rapid-growth companies with counsel on how to prepare their organizations for success in the competitive space.

    Andrew Fish is Chief Strategy Officer of AdvaMed, the leading trade association advancing medical technology in the U.S. and around the world. As chief strategy officer, Mr. Fish leads the association’s strategic planning, oversees AdvaMed's global, regulatory, and payment departments, and coordinates the development and operations of AdvaMed’s membership divisions and sectors.

    Dr. Denise Hines is current Chair of the North America Board of the Health Information & Management Systems Society (HIMSS), and is actively involved in HIMSS’ Women in Health IT initiatives that promote diversity and recognition.  She is CEO of eHealth Services Group and serves as Executive Director of Georgia’s statewide health information exchange (HIE).

    “The Southeastern medtech industry as a whole shows incredible growth and promise, and the diverse entries from across the region reflect that growth,” said Jason Rupp, Executive Director of SEMDA.  “PitchRounds gives us the chance to see the future come to life before our eyes with cutting-edge innovation and game-changing advancements in medical technology, devices and diagnostics from some of America’s brightest minds.”

    The SEMDA conference typically attracts more than 400 executives in medtech and life sciences from throughout the United States and has become a must-attend for the medtech community. Registration is strong but space is still available, noted Mr. Rupp.  Persons interested in attending can review the agenda, speakers and registration details online at http://www.semda.net.

    “These presenters and companies demonstrate that SEMDA has evolved into a truly regional organization that embraces and represents a diverse collective of medtech startups, universities, corporate organizations, investment resources, suppliers and capabilities from across the southeastern United States,” Mr. Rupp added.

    About SEMDA

    The Southeastern Medical Device Association (SEMDA) is a regional non-profit trade association that supports and promotes medical device and medical device data system (MDDS) companies in the Southeast. Created in 2004, the association provides unique educational resources to accelerate device development and achieve commercial success with access to funding, education, and networking opportunities for medical device companies, inventors, physicians, investors, tech transfer offices, universities, sponsors, and service providers interested in growing the medical device industry in the Southeast.

     

     

     

    Invited and scheduled to present at PitchRounds 2018

     

    LATER STAGE (RAISING SERIES A OR LATER)

    Company

    Name

    City/Town

    ST

    Kiyatec

    Matt Gevaert

    Greenville

    SC

    Intent Solutions

    Sam Zamarippa

    Atlanta

    GA

    Moterum

    David Huizenga

    Greenville

    SC

    Diamond Orthopedic

    JD Williams

    Charlotte

    NC

    Circulogene

    Mike Mullen

    Birmingham

    AL

    Sweetbio

    Kayla Rodriguez Graff

    Memphis

    TN

    Xhale, Inc.

    Douglas Crumb

    Gainesville

    FL

    Embody LLC

    Jeffrey Conroy

    Norfolk

    VA

    nfant

    Lou Malice

    Atlanta

    GA

    Kyndermed

    Melanie Simmons

    Tallahassee

    FL

    Raiven

    Jim Stefansic

    Nashville

    TN

    Fraudscope

    Musheer Ahmed

    Atlanta

    GA

     

     

     

     

     EARLY STAGE

    Company

    Name

    City/Town

    ST

    Zylö Therapeutics

    Scott Pancoast

    Greenville

    SC

    Sanguine Technologies Inc.

    John Forrest

    Charleston

    SC

    Accessible Diagnostics, LLC

    John Warner

    Greenville

    SC

    VitalFlo

    Luke Marshall, Ph.D.

    Raleigh

    NC

    Cryogenix, LLC

    John Baatz

    Charleston

    SC

    Aravis BioTech LLC

    Jeffrey Anker

    Greenville

    SC

    Purilogics, LLC

    Jinxiang Zhou

    Greenville

    SC

    OrthoScrews, LLC

    Zoe Guckien

    Tuscaloosa

    AL

    DiaTech Diabetes Technology

    John Gray

    Tallahassee

    FL

    Proof Biotechnologies, Inc

    Chang Kang

    Columbia

    SC

    PivotSC LLC/ XtremedX

    Frank Patterson

    Greenville

    SC