Meet 7 Femtech Companies Innovating In The Area Of Ovarian Health, Breast And Gynecological Cancers

Most cancers ranks as the leading or second leading reason for untimely loss of life amongst 30-69-year-old people in 134 international locations internationally, with the Worldwide Company for Analysis on Most cancers forecasting the worldwide most cancers burden to extend by about 60% from 2018 to 2040 — at a time when the variety of pathologists accessible to fulfill this enhance in workload is predicted to proceed to say no.

Breast most cancers is the most commonly occurring most cancers in girls and the second commonest most cancers general.

Ovarian most cancers ranks fifth in most cancers deaths amongst girls, accounting for extra deaths than every other most cancers of the feminine reproductive system. A lady’s danger of getting ovarian most cancers throughout her lifetime is about 1 in 78. 94% of girls with ovarian most cancers expertise signs nonetheless 80% of instances are recognized too late (stage III and IV) leading to a five-year survival fee of solely 28%. Globally, 225,500 new cases of ovarian most cancers are recognized annually.

This time final century, the common girl died earlier than her ovarian perform failed. Menopause was a comparatively uncommon phenomenon. In the present day, girls routinely outlive their ovarian perform, however at nice value to their well being and vitality after center age. Additionally, far earlier than the menopause transition, over 30% of girls world wide are impacted by suboptimal ovarian perform. These girls expertise situations like PCOS, endometriosis, and infertility consequently. Endometriosis, for instance, impacts virtually 200 million women worldwide and has a healthcare value burden of $78 billion in the U.S. alone. Regardless that these are extremely prevalent situations that set the stage for much more severe morbidities down the street like metabolic situations, autoimmune issues, and heart problems, we nonetheless have only a few therapeutics that may assist.

Beneath are seven extremely modern corporations on this house, bringing new game-changing options to the market and disrupting sectors the place we haven’t seen a lot innovation lately. These corporations will, hopefully, change the narrative round situations and diseases which have lengthy been underneath researched and missed.

4D Path – breast most cancers diagnostic and precision oncology platform

When Satabhisa Mukhopadhyay, Ph.D., cofounder and Chief Scientific Officer at 4D Path, and her group began the corporate in 2016, she knew that their primary focus of analysis can be discovering new data they believed existed throughout the micro-environment of most cancers mutations with a purpose to create a more practical strategy to diagnosing most cancers and serving to to information efficient therapy. “This was vital to us as a result of most cancers doesn’t discriminate by age, financial situation, intercourse, ethnicity, or geography. It touches virtually everybody in some private method, and our household has been no exception,” begins her story Mukhopadhyay.

Historically, following affirmation of most cancers from an preliminary biopsy, auxiliary testing is required to be taught extra in regards to the molecular nature of most cancers (corresponding to hormonal standing), to place the affected person on a exact therapy path. This will value the affected person important money and time and, in rural or growing areas, the provision of such assessments could also be extraordinarily restricted. “At 4D Path, we wish to create an end-to-end platform that would help pathologists and clinicians in unveiling beforehand hidden data purely from mobile snapshots of tissue or liquid with out using pricey antibody stains, and that would result in an correct analysis and a extra thorough understanding of most cancers’s nature from the affected person’s preliminary biopsy,” explains Mukhopadhyay.

4D Path raised preliminary fundings by means of three rounds of seed financing from 2016 to 2019 and a bigger quantity in 2021, with the pandemic, fortunately, not likely posing an impediment of their means to entry capital. The corporate has additionally secured a U.S. patent overlaying its core expertise. “The FDA granted us Breakthrough Device Designation for our first software-as-a-medical-device answer, the 4D Q-plasia OncoReader Breast, which is designed to enhance the diagnostic accuracy of breast most cancers options over the prevailing normal of care,” provides Mukhopadhyay. The corporate established a long-term partnership with the College of Leeds within the UK, a number one institute in digital pathology, and just lately, have begun to interact the Nationwide Well being Service (NHS) within the U.Ok. to design a large-scale subject trial. Moreover, they’ve been actively partaking key opinion leaders (KOLs) throughout pathology and oncology, establishing partnerships with pathology distributors, and are within the course of of creating a relationship with a serious U.S. Most cancers Analysis Institute for a number of validation trials.

Though their preliminary focus is on breast most cancers, the corporate is actively engaged on growing merchandise for ovarian most cancers, cervical cytology, pores and skin most cancers, and, typically, round immunotherapy in numerous cancers.

AOA Dx – a biotech firm targeted on early-stage ovarian most cancers detection

When AOA’s cofounders – Oriana Papin-Zoghbi, Anna Jeter and Alex Fisher, met a number one oncology researcher at McGill College working in direction of growing the primary early-stage ovarian most cancers liquid biopsy diagnostic check, they knew it was a match. “We wished to mix all of our talent units to show this imaginative and prescient into actuality. We launched our firm, AOA Dx, in 2020,” shares Papin-Zoghbi.

This Y Combinator and VC-backed biotech firm is concentrated on early-stage ovarian most cancers detection, growing a liquid biopsy check that exhibits wonderful ends in the early analysis of ovarian most cancers by means of evaluation of novel tumor markers. Papin-Zoghbi and her group are at the moment engaged on growing their first check to market – a diagnostic check for ovarian most cancers, and plan to run medical research to additional show the expertise. They’re additionally seeking to develop partnerships particularly with girls’s well being clinics corresponding to Tia Clinic and Maven Clinic to run medical trials and sooner or later supply the check to girls.

Early analysis of ovarian most cancers dramatically improves the survival fee. When detected early, virtually 95% of ovarian most cancers sufferers dwell greater than 5 years after their analysis — however solely round 15% of ovarian cancers are discovered early. Beforehand referred to as the “silent killer” believed to be asymptomatic, latest large-scale trials present that over 90% of girls expertise signs for a lot of months – corresponding to pelvic ache, bloating, and fatigue – and the overwhelming majority search medical intervention. On account of a scarcity of an correct check at early levels, lots of the signs are attributed to different causes, and due to this fact, the most cancers is usually not recognized till Stage 4: a degree at which it has already unfold — or metastasized— to different components of the physique, and the five-year survival charges drop to under 20%.

By 2035 new instances of ovarian most cancers will enhance by 55% and deaths will enhance by 67%. Nonetheless, if most of those instances might be detected at a really early stage, the variety of deaths from this illness can be diminished by half, admits Papin-Zoghbi.

“With a product like ours, we may catch the illness earlier and provides girls an actual likelihood at survival,” she concludes.

Celmatix – a preclinical-stage girls’s well being biotech firm targeted uniquely on ovarian biology

Piraye Beim, founder and CEO of Celmatix, was on the entrance traces of precision medication in girls’s well being oncology throughout her Ph.D. work at Weill Cornell College and Memorial Sloan Kettering Most cancers Heart (NYC) within the early 2000s. When her analysis focus shifted from oncology to girls’s reproductive well being, sadly, it felt like she had been teleported a number of many years again technologically. “The ‘lightbulb’ second got here after I turned 30 whereas I used to be doing my post-doctoral analysis in mammalian embryology on the College of Cambridge within the U.Ok. Lots of the career-focused girls in my life had been beginning to expertise fertility difficulties, and likewise on a private stage, I began to really feel the influence of not getting access to higher details about my reproductive well being or timeline,” shares Beim. That was the inspiration for founding Celmatix in 2009: to construct that lacking information layer holding the ladies’s well being subject again, and to take action by means of a platform that may permit them to quickly translate the insights from that information into higher data and therapies for girls navigating their pre-menopausal years.

Beim’s work resulted in pioneering the brand new therapeutic class of ‘ovarian well being’, a time period she and her group coined just a few years in the past to distinguish their strategy from one which equates the ovary with solely copy. “On the heart of our analysis is our Anti-Müllerian Hormone (AMH) drug program targeted on novel mechanisms of regulating ovarian folliculogenesis that can permit us to handle prevalent however underserved situations like polycystic ovary syndrome (PCOS) and likewise unlock new indications like controlling not simply menopausal signs however the menopausal transition itself,” describes Beim. An AMH test is commonly used to examine a lady’s means to provide eggs that may be fertilized for being pregnant, with AMH ranges serving to to indicate what number of potential egg cells a lady has left. This is called the ovarian reserve. AMH assessments can also be used to foretell the beginning of menopause, discover out the rationale for early menopause, assist discover out the rationale for amenorrhea – the dearth of menstruation, assist diagnose polycystic ovary syndrome (PCOS), monitor girls who’ve sure varieties of ovarian most cancers and extra.

Along with their lead AMH program, Celmatix has an ongoing collaboration with Evotec and Bayer primarily based on novel drug targets they recognized for PCOS, and so they have additionally acquired grants from the Invoice & Melinda Gates Basis targeted on figuring out novel non-hormonal contraception drug targets.

So far, Celmatix has raised over $100 million, primarily from Topspin Companions, Evotec SE, Slome Capital, and Particular Conditions Life Sciences Innovation Fund. When requested how the pandemic affected their fundraising efforts, Beim admits that they’ve been largely unaffected since, as a girls’s well being biotech firm, they’ve all the time been pragmatically targeted on pursuing drug applications that sort out clear unmet wants “in a method that insulates us from the up and down swings of hype cycles.”

Curiva – an organization growing diagnostic patches designed for the detection of gynecologic oncology malignancies

For Eydis Lima, founding father of Curiva, the thought to begin her firm got here to fruition as she was doing ovarian most cancers analysis at Yale College after collaborating in a Yale Well being Hackathon throughout the winter of 2016. One yr later, she enrolled on the College of Notre Dame in a Grasp’s Diploma in Entrepreneurship with a purpose to de-risk the thought’s areas of expertise and enterprise growth. A key cause for founding the corporate was as a result of she grew to become pissed off seeing sufferers on the Yale-New Haven-Smilow Most cancers Hospital suffer from gynecologic cancers each within the ready areas and the working rooms. So for Lima, to this point, Curiva’s mission is consultant of enhancing the lives of every affected person at Smilow hospital and past.

Curiva’s enterprise mannequin is that of analysis use solely (RUO) gross sales initially and later direct medical gross sales, with the distinctive promoting level being the kind of information and medical data their biomarkers give to physicians and sufferers. “Our patent-pending expertise, diaPatch, is a diagnostics patch for the detection of high-risk (CIN) stage cervical most cancers. So our preliminary demographics are the high-risk sufferers which have a historical past of cervical most cancers of their household or have had a collection of irregular Pap smears and now discover themselves in want of a colposcopy,” shares Lima.

Since 2018, Lima’s enterprise has been funded principally by means of her private capital and smaller angel funding cheques. As their greatest milestones this yr, Lima highlights submission of their first NIH (Nationwide Institutes of Well being) SBIR (Small Enterprise Innovation Analysis) Part I grant firstly of January of which funding standing she is going to know extra about in April. “We couldn’t have completed this with out our new co-founder and Chief Scientific Officer’s onerous work, Tracie McGinnity, Ph.D., additionally a Notre Dame alumnus. Lastly, now we have a diaPatch prototype that’s being optimized to be a completely purposeful minimal viable product (MVP) by the top of this yr. And will probably be able to be examined in medical pilots. For the time being we’re laser-sharp targeted on fundraising efforts and would like to create extra collaborations with medical foundations, key opinion leaders (KOLs), most cancers analysis institutes, in addition to philanthropic entities just like the Eli Lilly Basis and the Invoice & Melinda Gates Basis. We consider our product diaPatch can influence the methods by which cervical most cancers prevention is addressed and brings that international variety of greater than 300,000 girls worldwide dying from the illness considerably down. Completely discovering that product-market match with this preliminary space of utility will speed up Curiva in direction of changing into a platform expertise within the FemTech trade,” she concludes.

Olea Medical – an organization growing semi-automatic purposes for pelvic and breast MR imaging

The thought behind Olea Medical is to develop and put within the palms of clinicians superior post-processing instruments which are sufficiently dependable, strong, and environment friendly for the administration of among the deadliest situations, corresponding to stroke and most cancers.

“We had been the primary to standardize the post-processing of essentially the most advanced MRI sequences used for the administration of extreme, life-threatening situations and likewise to introduce strategies which are rather more correct, optimized and appropriate with medical follow and emergency necessities,” explains Anca Mitulescu, VP Scientific Affairs at Olea Medical. What pushed Mitulescu and her group to commercialize their first product – Olea Sphere®, an modern post-processing software program suite for MR and CT perfusion imaging that considerably hurries up the analysis course of and makes the analysis of a number of pathologies a lot simpler – from neuro illnesses to breast cancers to musculoskeletal issues, was an alarming statement that that they had made on the time, specifically that there was no efficient software, when it comes to accuracy and processing time, permitting medical doctors to make a therapeutic determination shortly sufficient to hope for a very good prognosis following a stroke. Ischemic stroke, which accounts for 87% of strokes, is a matter of time, figuring out that about 4 million neurons die each minute after the incidence of the stroke.

Moreover, for the final 4 years, Mitulescu and her group have been growing a devoted post-processing answer for breast lesions evaluation that has been just lately CE-marked and FDA-cleared for medical use. This product, centered on MRI for breast tumors, is a serious achievement in girls’s imaging and is optimized for the characterization and the follow-up of breast lesions, but additionally to help throughout breast biopsies. The thought is to assist the clinicians be extra assured of their analysis, scale back exams do-over by enhancing pictures usability even in instances of affected person actions, permitting clinicians to judge therapy efficacy, for the affected person’s profit.

Additionally, they’re constantly investing in girls’s well being analysis applications with sturdy medical collaborations at the moment ongoing, on endometriosis and breast most cancers. “We’re speaking right now a couple of prevalence of 1 in 10 girls troubled by endometriosis, a analysis delay of no less than seven years, and lots of uncertainty when deciphering medical pictures of this pathology. We’re adamant to vary this with our options,” provides Mitulescu.

OncoGenomX – an organization constructing AI-enabled options for the lasting metastasis prevention

Breast most cancers is the most common cancer in women within the U.S., aside from pores and skin cancers. It’s about 30% (or 1 in 3) of all new feminine cancers annually. The American Most cancers Society’s estimates for breast most cancers in the US counsel that, in 2022, about 287,850 new instances of invasive breast most cancers can be recognized in girls and about 43,250 girls will die from breast most cancers. On prime of that, every second girl with hormone-dependent breast most cancers is undertreated or overtreated, in line with analysis by the American Most cancers Society. Translated in numbers, that’s 135,000 girls per yr.

Based on Dr. Mark Pegram, the primary director of the Breast Most cancers Oncology Program at Stanford Girls’s Most cancers Heart and the Susy Yuan-Huey Hung Professor of Oncology, latest research have proven that an growing variety of breast most cancers sufferers are nonetheless overtreated. And with an growing old demographic, the numbers proceed to rise. “There isn’t any doubt that the issue of overtreatment wants pressing decision. Certainly, bringing the appropriate therapy to the appropriate affected person will go an extended approach to avert pointless dangers from overtreatment unintended effects, in addition to lead to higher cost-effectiveness in well being methods,’ he shared with me in an e-mail.

“The primary causes for this and the worsening of the scenario over the previous 15 years are overdiagnosis, worry of recurrence, unintended effects, therapy failure, and monetary hardship. As an oncologist, I do know that within the absence of a dependable process enabling the optimum therapy, as a rule, the possibilities of stopping breast most cancers won’t enhance considerably, spending on breast most cancers remedy will proceed to extend and the chance of suboptimal remedy and end result will stay unchanged,” explains Wolfgang Hackl, founder and CEO of OncoGenomX, a Swiss-based firm on a mission to turn into one of the best therapy steering software program for breast most cancers and to make sturdy metastasis prevention an choice and a actuality for all sufferers. Its first product, PredictionStar – a novel methodology for figuring out the right most cancers therapy routine for everlasting prevention of metastasis, has the potential to successfully clear up the above issues with an 85% likelihood of figuring out one of the best therapy choice. “This outperforms the medical determination choices of the competitors (55% likelihood),” provides Hackl.

Enabled by proprietary AI and machine studying algorithms, PredictionStar interprets the outcomes of medical and histological picture assessments, tumor and blood gene assessments, by empowering oncologists with one of the best software to find out essentially the most efficacious therapy for sturdy metastasis prevention. This implies it will probably successfully scale back the dangers of over or under-treatment, diminish prices, and enhance effectivity.

Since its launch in October 2020, the corporate has raised round $1.1 million, partly from undisclosed personal traders, partly as non-diluted analysis funds. “To finance the transformation of OncoGenomX from an idea and discovery right into a product growth group, we at the moment are seeking to increase $20 million to turn into commercialization and medical study-ready by 2024,” concludes Hackl.

Syrona Well being – an worker advantages answer for these affected by continual gynecological well being situations

When Chantelle Bell, cofounder of Syrona Health, met her enterprise associate Anya Roy, they shared the identical difficulties with navigating the healthcare system attributable to their very own continual gynecological well being situations. There was a definite lack of analysis throughout the subject of gynecological well being, particularly inside endometriosis, so that they constructed Syrona Well being as a response to that.

Syrona Well being is an worker advantages platform and research-driven app, and what’s completely different about it’s that the whole lot the app supplies is built-in with analysis and so they’re upfront about this with customers. “When customers join they’ll both opt-in or opt-out of analysis however opting in, permits us to contribute to enhancing the restricted analysis throughout the house of endometriosis,” explains Bell.

Syrona’s customers are round 45% of the workforce who will expertise a gynecological situation throughout their lifetime, from infertility to endometriosis and menopause. Based on Bell, many individuals with endometriosis and different gynecological situations typically go away the workforce attributable to a scarcity of help and entry to healthcare. “We wish to change that and empower girls at work (and likewise at dwelling) to grasp and handle their healthcare.” The Syrona app gives personalised healthcare with monitoring, insights, curated merchandise, entry to specialists to get knowledgeable recommendation by means of on-line consultations, in addition to a neighborhood that understands what you’re experiencing.

Backed by Y Combinator, the corporate has additionally raised cash from accelerators such BGV, a number of angel traders and has gained a number of Innovate UK grants up to now. With over 7,500 customers within the U.Ok., Eire, and the U.S., Bell and her group have additionally made some nice partnerships with medical system corporations, hospital teams, and pharma corporations simply to call just a few.

“From navigating the challenges of fertility and being pregnant to different ‘girls’s issues’ corresponding to menopause or menstruation, speaking about feminine reproductive points continues to be seen as taboo. This will go away staff feeling marginalized and unheard and is additional exacerbated if the particular person is trans or non-binary. We’re right here to vary that,” concludes Bell.