MDxHealth SA in Irvine has rolled out its third test, AssureMDx. The noninvasive urine-based test assesses the risk of bladder cancer in patients diagnosed with hematuria—blood in the urine.
The test can help identify patients with more risks for bladder cancer and therefore in need of cystoscopy, as well as rule out those—up to 77% of hematuria patients—who don’t need a cystoscopy, the company said.
The current standard for bladder cancer diagnosis is cystoscopy—a procedure involving inserting a thin tube with a camera and a light on the end through the urethra to see the inside of the bladder. A variety of urinary system problems call for it, including bladder tumors, stones and cancer.
MDxHealth is a diagnostics company that uses epigenetics information to provide personalized diagnosis and treatment of cancer.
“AssureMDx is our third molecular diagnostic test in the field of urology, and our second liquid biopsy test,” said Chief Executive Dr. Jan Groen. He added that the company will continue its mission to deliver molecular tests that “improve patient outcomes while reducing healthcare costs.”
The company’s European headquarters are in Herstal, Belgium, and it has a 1,735-square-foot diagnostic facility in the Netherlands. Its U.S. headquarters and laboratory facility, totaling 19,793 square feet, are in Irvine. It has 160 employees companywide and generated about $30 million in sales last year.
The company is traded on the Brussels Stock Exchange and has about a $263 million market cap.
MDxHealth said that about 11 million patients a year are referred to a urologist for clinical evaluation due to hematuria and that 3% to 28% of them are diagnosed with bladder cancer.
The company has two other molecular tests. SelectMDx, which it launched last March, is also a urine-based “liquid biopsy test” that assesses patients’ risk for prostate cancer. The other test is ConfirmMDx, an epigenetic, tissue-based procedure for early detection of prostate cancer. ConfirmMDx was launched in 2012.
SelectMDx is available worldwide, and the other two tests are available only in the U.S. ConfirmMDx is qualified for Medicare reimbursement.
C Series
Axonics Modulation Technologies Inc. announced that it completed a $20.5 million second closing of its series C financing, bringing the total amount of capital raised in the round to $35 million. It will use proceeds to support a pivotal clinical study in patients with overactive bladder to gain Food and Drug Administration approval.
The Business Journal reported about a month ago on the Irvine-based medical device company’s $14.5 million first closing. The company said it was targeting a $30 million raise.
Axonics develops a rechargeable sacral neuromodulation system designed to treat patients suffering from overactive bladders, urinary retention and fecal dysfunction. Its device received approval last year to market in Europe and Canada.
The second closing included two new investors: Glide Healthcare Partners B.V. in the Netherlands, with a U.S. office in Cambridge, Mass., and CICA Inc. in La Jolla.
Geoff Pardo, a partner at Glide Healthcare, joined Axonics’ six-member board of directors.
Axonics’ major stockholders, including Edmond de Rothschild Investment Partners in Paris, Advent Life Sciences in London, Cormorant Asset Management LLC in Boston, Boston-based Legend Capital and Geneva-based NeoMed Management, also participated in the latest round.
Axonics raised $32.6 million and $38.5 million, respectively, in its series A and series B financings. It’s raised over $100 million to date.
Marketing Suit
Allergan PLC settled a marketing lawsuit, agreeing to pay $13 million to the U.S. and 19 states. The whistleblower suit was filed in 2009 and alleged that the pharmaceutical company engaged in a kickback scheme to induce eye care doctors to write prescriptions for Allergan eye care products, including dry-eye eye drop Restasis and other eye drugs for off-label uses. The products were paid for by Medicare and Medicaid.
The complaint was brought by two Philadelphia-area ophthalmologists.
Allergan is chartered in Dublin, Ireland, but maintains U.S. headquarters in Parsippany, N.J. Its Irvine campus is home to its eye care, aesthetics and Botox plastic surgery and therapeutic products divisions.
Bits & Pieces
Hoag Hospital Irvine has been certified as a primary stroke receiving center by DNV GL Healthcare USA Inc. The hospital’s Irvine campus joins Newport Beach-based Hoag Memorial Hospital Presbyterian as a DNV GL facility affirmed to provide a full range of stroke-related medical care, including diagnosis, treatment and rehabilitation. The requirements for DNV GL international healthcare accreditation programs have been approved by the Centers for Medicare and Medicaid. … Allied Anesthesia Medical Group Inc. in Santa Ana launched a new medical blog to better reach patients, addressing topics such as eating before surgery and pregnancy-related issues. The group plans to include contributions from other doctors and experts, “even outside the field of anesthesia,” it said in a statement. Allied Anesthesia provides adult and pediatric anesthesia services to St. Joseph Hospital-Orange, Children’s Hospital Orange County, St. Jude Medical Center in Fullerton and other facilities in Southern California.
