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Zo gaat dat 27 oktober 2016 08:46

1

Hierbij een poging om ook een keer iets inhoudelijks bij te dragen. ;-) Ik heb op basis van de persberichten een overzichtje gemaakt van alle deals tot nu toe.

ConfirmMDX

HCSC: 15 miljoen leden
Highmark: 5,2 miljoen leden
Independence: 8,5 miljoen leden
Medi-Cal: 12 miljoen leden
Cigna:90 miljoen customer relationships (website Cigna)
EHC Innovation: Polen
Priority Health: 720.000 leden

SelectMDx

SouthGenetics Inc: Centraal en Zuid Amerika
EHC Innovation: Polen
HIFU CLINIC: Polen
Fortified Provider Network (FPN): 5 miljoen leden
America's Choice Provider NetworkACPN: 24,75 miljoen leden

[verwijderd] 31 oktober 2016 16:44

0

MDxHealth Announces Unique CPT Code Awarded for ConfirmMDx from the American Medical Association

Current Procedural Terminology code will facilitate reimbursement

IRVINE, CA, and HERSTAL, BELGIUM - October 31, 2016 - MDxHealth SA (Euronext: MDXH.BR), today announced that its ConfirmMDx® for Prostate Cancer test has been granted a Category I MAAA Current Procedural Terminology (CPT) code by the American Medical Association (AMA).

"Obtaining Category I CPT code for ConfirmMDx is an important reimbursement milestone that can only be achieved once there is sufficient evidence demonstrating the test improves patient outcomes, has the support of the specialty medical associations, inclusion in medical guidelines and widespread physician adoption," stated Dr. Jan Groen, CEO of MDxHealth. "We believe that ConfirmMDx has become a 'standard of care" for the management of men with a with a previous negative prostate biopsy and that this Category I designation will facilitate negotiations with payors and most importantly, timely reimbursement."

CPT Category codes are granted and regulated by the AMA CPT Editorial panel and are widely used by government payors and insurance companies to describe health care services and procedures for reimbursement purposes. The unique ConfirmMDx CPT code, effective in January 2018, will streamline reimbursement from US government programs such as Medicare and Medicaid and commercial health insurance companies. Criteria for the Category I MAAA designation include literary documentation of clinical efficacy and consistency with current medical practice as well as widespread adoption and use across the US and with a frequency consistent with intended clinical use.

[verwijderd] 2 november 2016 18:26

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MDxHealth Provides Third Quarter 2016 Business Update
Revenue for the first nine months up 84% to $22 million

Continued strong growth attributed to increased payor coverage

IRVINE, CA, and HERSTAL, BELGIUM - November 2, 2016 - MDxHealth SA (Euronext: MDXH.BR), today announced its third quarter 2016 Business Update for the period ended September 30, 2016.

Dr. Jan Groen, Chief Executive Officer of MDxHealth, commented: "The sharp revenue growth has been driven by the strong increase in payor coverage for our lead product ConfirmMDx in the key U.S. market. We anticipate continuing acceleration in the adoption of ConfirmMDx among payors and physicians, broadening availability to patients and preventing thousands of unnecessary and often painful biopsies. In doing so we expect our strong Q3 performance to continue into Q4 and maintain our recently upgraded guidance for the full year."

"Since the launch of our SelectMDx 'liquid biopsy' test early 2016, we have tested more than 2,000 men, clearly showing the value of the test for both urologists and their patients," continued Dr. Groen. "This is further supported by the rapid adoption by the payor community, with nine insurance companies in the U.S. already covering the SelectMDx test."

Q3 Financial Highlights

Q3 total revenues increased 122% to $9.1 million (Q3 2015: $4.1 million); up 45% from Q2 2016 ($6.3 million)
Q3 net loss declined 46% to $2.7million (Q3 2015: $4.8million)
Year to date (first nine months) Financial Highlights

YTD 2016 total revenues increased 84% to $22 million (YTD 2015: $11.9 million)
YTD net loss of $10.3 million (YTD 2015: $10.3million)
Cash and cash equivalents at September 30, 2016, of $15.1 million
YTD (first nine months) Business Highlights

ConfirmMDx Highlights

Twenty-five commercial health plans established positive medical policy for ConfirmMDx, including major payors such as Cigna, Highmark BCBS, Independence BC and others.
ConfirmMDx covered under California Medical Assistance Program (Medi-Cal).
Commercial agreement for ConfirmMDx signed with The European Health Centre Innovation in Poland and South Genetics in Central/South America.
ConfirmMDx included in the 2016 NCCN Guidelines for Prostate Cancer Early Detection. The NCCN is an alliance of 26 world-leading cancer centers from across the U.S.
SelectMDx Highlights

Nine health plans have contracted to cover SelectMDx, including Multiplan, America's Choice Provider Network, Fortified Provider Network, Galaxy Health Network and others.
Five distribution agreements signed for SelectMDx, including with Cerba Healthcare in Benelux Region and France, Teva Pharmaceuticals in Israel, The European Health Centre Innovation, HIFU Clinic Prostate Cancer Centre in Poland and South Genetics in Central/South America.
Prospective, multicenter SelectMDx validation study published in the prestigious journal European Urology.
Post-Period Highlights

Health Care Services Corporation (BCBS of Texas, BCBS of Illinois, BCBS of Oklahoma, BCBS of New Mexico and BCBS of Montana), which serves more than 15 million members across the United States, issued positive medical policy on the ConfirmMDx® for Prostate Cancer test.
ConfirmMDx for Prostate Cancer has been awarded a unique Current Procedural Terminology (CPT) code by the American Medical Association. The Category I MAAA code will facilitate reimbursement from U.S. government programs such as Medicare and Medicaid as well as commercial health insurance plans. The CPT code will be effective as of January 2018.
Key non-audited financials as of September 30, 2016

Amounts at and for the three and nine months ended:

As of September 30, 2016 Q3 2016 First nine months 2016 Q3 2015 First nine months 2015
Total revenues 9,080 22,025 4,088 11,948
EBITDA (Loss) (2,456) (9,099) (4,708) (9,985)
Operating profit (EBIT) (2,673) (10,201) (4,827) (10,302)
Net loss (2,692) (10,310) (4,840) (10,324)
Number of outstanding shares 45,269,633 43,998,490
Cash and cash equivalents 15,151 35,111
Except for Outstanding Shares, amounts are in thousands of dollars

Commercial revenues up 84% for the first 9 months

Total Revenues for the first nine months of 2016 amounted to $22.0 million, representing 84% growth over the same period a year earlier, primarily due to an increase in ConfirmMDx test sales in the U.S.

Operating Expenses were $24.8 million in the first nine months of 2016, versus $17.6 million in the same period in 2015, with the increase attributable to our continued investment in product development, sales, marketing and the managed care sales team.

Net Loss of $10.3 million for the first nine months of 2016 is unchanged compared to the same period in 2015. Continued investment in U.S. commercial operations and a higher cost of sales due to increasing volumes of ConfirmMDx were offset by higher recognized sales revenues.

Cash Position as of September 30, 2016, was $15.1 million in cash and equivalents, compared to $35.1 million on September 30, 2015. Average net cash burn in the first nine months of 2016 was approximately $1.8 million per month.

Q4 and H1 2017 Outlook

The Company maintains its upgraded guidance for projected 2016 revenues, which are expected to increase by more than 60% over 2015. This sharp growth can be attributed to accelerated adoption of the ConfirmMDx for Prostate Cancer test by urologists in the U.S. The test's inclusion in the U.S. National Comprehensive Cancer Network (NCCN) Clinical Guidelines in Q1 2016 has facilitated successful contract negotiations with a number of new payors, leading to a significant increase in revenues. In addition, the Company believes that the recent award of a unique Category I CPT code for ConfirmMDx from the American Medical Association will streamline reimbursement from government and commercial payors, further accelerating adoption among payors and physicians.

For the acceleration of the second prostate cancer product SelectMDx, the Company has completed a health economic study for the Netherlands and data have been submitted for publication. The Company also completed a study comparing the SelectMDx test with MRI scan outcome data and intends to presents and publish these data. In preparation for the launch of MDxHealth's third product AssureMDx for bladder cancer, a multi-center clinical validation study has been completed and submitted for publication. Publication of these data is important to support a successful introduction and launch of the AssureMDx test.

MDxHealth maintains its guidance that underlying Earnings Before Interest, Taxes, Depreciation and Amortization (EBIDTA) for the year ended 2016 are expected to improve compared to 2015.

The Company continues to work towards broadening its portfolio and continues to make progress on the development of tests for the diagnosis of other indications, including kidney cancer, with the aim of providing a full suite of products for the diagnosis of urological cancers.

About MDxHealth

MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary gene methylation (epigenetic) and other molecular technologies and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.

Pokerface 2 november 2016 19:57

0

Uitbreiding aantal aandelen.
PB van 2 november 2016

MDxHealth Launches Equity Placement

THIS ANNOUCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURIDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW

IRVINE, CA, and HERSTAL, BELGIUM - November 2, 2016 - MDxHealth SA (Euronext Brussels: MDXH), announced today that it has launched an equity offering to raise an amount of approximately EUR 15 million by means of a private placement of new shares, with the possibility to increase the size of the placement to up to 4,526,962 new shares in total (representing close to 10% of the company's outstanding shares).

Degroof Petercam is acting as Sole Lead Manager and Bookrunner for the private placement, which will be structured as an accelerated bookbuilding. The bookbuilding procedure will commence immediately and is expected to close on November 2, 2016, subject to acceleration or extension of the timetable.

The net proceeds of the placement of the new shares will be used mainly to support and scale-up the Company's U.S.-based managed care and related healthcare reimbursement efforts, the sales and marketing efforts in the U.S. for ConfirmMDx and SelectMDx, and the sales and marketing and related commercialization efforts in Europe and the rest of the world for SelectMDx. In addition, depending on the amount raised, the net proceeds would be used to accelerate the product development of the AssureMDx bladder cancer test, and for general corporate purposes.

Trading in MDxHealth shares on Euronext Brussels will be suspended throughout the bookbuilding period. Trading in the stock is expected to resume following the publication of the results of the placement.

The company will announce the results of the placement as soon as possible after closing of the bookbuilding in a subsequent press release.

About MDxHealth
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary gene methylation (epigenetic) and other molecular technologies and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.

[verwijderd] 10 november 2016 07:05

0

Published: 07:00 CET 10-11-2016 /GlobeNewswire /Source: MDxHealth (R) / : MDXH /ISIN: BE0003844611

MDxHealth's AssureMDx Multi-Center Validation Study Published in the Journal of Urology

99% Negative Predictive Value could lead to 77% reduction in invasive cystoscopy procedures

IRVINE, CA, and HERSTAL, BELGIUM, November 10, 2016 - MDxHealth SA (Euronext: MDXH), today announced that a second clinical validation study, demonstrating the performance of its urine-based epigenetic test AssureMDx(TM) for Bladder Cancer, has been published in The Journal of Urology.

Prof. Dr. Ellen Zwarthoff, Erasmus MC Cancer Institute stated: "This pan-European multi-center validation study confirms the very high negative predictive value (99%) of the AssureMDx test. The clinical utility of this test lies in its ability to significantly reduce (77%) unnecessary invasive cystoscopy procedures in patients presenting with haematuria."

In the 200 patient study spanning three European countries, voided urine samples were collected from haematuria patients undergoing a cystoscopy procedure (n=97 Bladder Cancer, n=103 non-malignant) to rule out bladder cancer (BC) and analysed them using the AssureMDx biomarkers to determine an association between clinical risk variables. Combining the methylation and mutation markers with age led to an Area Under Curve (AUC) of 0.96 (95% CI 0.92-0.99, sensitivity 93% and specificity 86%). The AUC was higher in high grade tumors (1.00) compared to low grade tumors (0.93). The study demonstrated that AssureMDx can deliver an overall negative predictive value of 99%, based on the 5-10% prevalence of BC in patients with haematuria.

Annually, approximately a million haematuria patients are referred to urology for further clinical evaluation, with a large proportion of patients subjected to an invasive cystoscopy procedure, however less than 10% are diagnosed with BC. The authors believe that in the clinic, utilization of the test could potentially result in a 77% reduction in diagnostic cystoscopies.

"These very positive results further underscore the clinical validity and utility of AssureMDx and publication of these data will support the Q4 beta launch in the US, with a full scale launch of the test nationwide in early 2017," reported Dr. Jan Groen, Chief Executive Officer of MDxHealth. "Cystoscopies lead to high diagnostic costs and patient burden, so the ability of our test to improve patient selection for this invasive and sometimes painful procedure, will undoubtedly reduce costs and over-testing."

The full paper is accessible via the online edition of the Journal of Urology.

About AssureMDx(TM) for Bladder Cancer
Annually it is estimated that over 1 million patients with haematuria (blood in urine) are referred to urologists for fear of bladder cancer however, while 90% of bladder cancer patients present with haematuria, only 5-10% of haematuria patients are diagnosed with bladder cancer. The vast majority of these patients could avoid an invasive cystoscopy procedure. AssureMDx for Bladder Cancer is a non-invasive, urine-based DNA methylation and mutation test designed to improve the identification of patients at increased risk for bladder cancer who will benefit from further clinical evaluation. The test delivers a negative predictive value (NPV) of 99% for bladder cancer, helping to reduce unnecessary invasive cystoscopy procedures by approximately 70%, thereby reducing healthcare costs.

[verwijderd] 10 november 2016 08:57

0

Voor de Bio-liefhebbers.

10-11-2016 07:00:26

PERSBERICHT: ABLYNX KONDIGT UITOEFENING WARRANTS AAN

GEREGLEMENTEERDE INFORMATIE

GENT, België, 10 november 2016 - Ablynx [Euronext Brussels: ABLX;
OTC: ABYLY] kondigde vandaag aan, in overeenstemming met titel II van de
Wet van 2 mei 2007 en het Koninklijk Besluit van 14 februari 2008, dat
de Vennootschap 938 nieuwe aandelen heeft uitgegeven in ruil voor
EUR5.102,72 als resultaat van het uitoefenen van warrants.

Als resultaat van deze transactie heeft Ablynx nu 60.921.732 uitstaande
aandelen.

Het totaal aantal rechten (warrants) om in te schrijven op nog niet
uitgegeven stemrechtverlenende effecten bedraagt op heden 2.623.080
hetgeen tevens gelijk is aan het totaal aantal stemrechten dat bij de
uitoefening van die warrants kan worden verkregen. Vandaag zijn er 1.000
converteerbare obligaties uitstaand die, bij conversie van dergelijke
converteerbare obligaties, aan de houders daarvan het recht geven op
7.733.952 aandelen van de Vennootschap in het aggregaat.

Over Ablynx

Ablynx www.ablynx.com/ is een biofarmaceutische onderneming
actief in de ontwikkeling van Nanobodies(R)
www.ablynx.com/technology-innovation/... ,
gepatenteerde therapeutische eiwitten gebaseerd op enkel-keten
antilichaamfragmenten die de voordelen combineren van medicijnen
gebaseerd op conventionele antilichamen en kleine chemische moleculen.
Ablynx is toegewijd om nieuwe medicijnen te ontwikkelen die een
duidelijk verschil kunnen maken voor de samenleving. De Vennootschap
heeft vandaag meer dan 45 programma's
www.ablynx.com/rd-portfolio/overview/ in eigen ontwikkeling en
met partners in diverse therapeutische indicaties zoals inflammatie,
hematologie, immuno-oncologie, oncologie en ademhalingsziekten. Ablynx
heeft overeenkomsten met verscheidene farmaceutische bedrijven waaronder
AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc.,
Merck KGaA, Novartis, Novo Nordisk en Taisho Pharmaceutical. De
onderneming is gevestigd in Gent, België. Meer informatie is te
vinden www.ablynx.com.

[verwijderd] 10 november 2016 09:07

2

quote:
Bogo schreef op 10 november 2016 08:57:
Voor de Bio-liefhebbers.

10-11-2016 07:00:26

PERSBERICHT: ABLYNX KONDIGT UITOEFENING WARRANTS AAN

GEREGLEMENTEERDE INFORMATIE

GENT, België, 10 november 2016 - Ablynx [Euronext Brussels: ABLX;
OTC: ABYLY] kondigde vandaag aan, in overeenstemming met titel II van de
Wet van 2 mei 2007 en het Koninklijk Besluit van 14 februari 2008, dat
de Vennootschap 938 nieuwe aandelen heeft uitgegeven in ruil voor
EUR5.102,72 als resultaat van het uitoefenen van warrants.

Als resultaat van deze transactie heeft Ablynx nu 60.921.732 uitstaande
aandelen.

Het totaal aantal rechten (warrants) om in te schrijven op nog niet
uitgegeven stemrechtverlenende effecten bedraagt op heden 2.623.080
hetgeen tevens gelijk is aan het totaal aantal stemrechten dat bij de
uitoefening van die warrants kan worden verkregen. Vandaag zijn er 1.000
converteerbare obligaties uitstaand die, bij conversie van dergelijke
converteerbare obligaties, aan de houders daarvan het recht geven op
7.733.952 aandelen van de Vennootschap in het aggregaat.

Over Ablynx

Ablynx www.ablynx.com/ is een biofarmaceutische onderneming
actief in de ontwikkeling van Nanobodies(R)
www.ablynx.com/technology-innovation/... ,
gepatenteerde therapeutische eiwitten gebaseerd op enkel-keten
antilichaamfragmenten die de voordelen combineren van medicijnen
gebaseerd op conventionele antilichamen en kleine chemische moleculen.
Ablynx is toegewijd om nieuwe medicijnen te ontwikkelen die een
duidelijk verschil kunnen maken voor de samenleving. De Vennootschap
heeft vandaag meer dan 45 programma's
www.ablynx.com/rd-portfolio/overview/ in eigen ontwikkeling en
met partners in diverse therapeutische indicaties zoals inflammatie,
hematologie, immuno-oncologie, oncologie en ademhalingsziekten. Ablynx
heeft overeenkomsten met verscheidene farmaceutische bedrijven waaronder
AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc.,
Merck KGaA, Novartis, Novo Nordisk en Taisho Pharmaceutical. De
onderneming is gevestigd in Gent, België. Meer informatie is te
vinden www.ablynx.com.

Kunnen we alle bedrijven die niets met MDX te maken hebben gewoon achterwege laten op dit forum

Dank u

[verwijderd] 10 november 2016 09:16

0

quote:
Onderbouwer schreef op 10 november 2016 09:07:
[...]

Kunnen we alle bedrijven die niets met MDX te maken hebben gewoon achterwege laten op dit forum

Dank u

MDxHealth: Het inhoudelijke topic

[verwijderd] 10 november 2016 09:25

1

quote:
Onderbouwer schreef op 10 november 2016 09:07:
[...]

Kunnen we alle bedrijven die niets met MDX te maken hebben gewoon achterwege laten op dit forum

Dank u

Je hebt helemaal gelijk, was een beetje dom mijn nedirige excuses.

Pokerface 10 november 2016 12:05

0

MDxHealth Licenses Epigenetic Technology to oncgnostics GmbH for Cervical Cancer Test

IRVINE, CA, and HERSTAL, BELGIUM - January 14, 2015 - MDxHealth SA (Euronext: MDXH), a leading molecular diagnostics company in the field of personalized cancer treatment, today announced that it has granted a limited worldwide license for its patented methylation specific PCR (MSP) technology to oncgnostics GmbH in Jena, Germany.

"oncgnostics is pleased to obtain a license to MDxHealth's proprietary epigenetic technology for use in our cervical cancer diagnostics programs. This technology allows for the accurate and sensitive assessment of DNA methylation markers included in our first test GynTect®, which is intended for the early detection of cervical neoplasias that may progress to cancer," said Dr. Alfred Hansel, Chief Executive Officer of oncgnostics.

Under the agreement, MDxHealth grants oncgnostics a limited, non-transferable, non-exclusive, worldwide license for its patented methylation specific PCR (MSP) technology for diagnostic applications in cervical cancer. In return, MDxHealth will receive upfront and milestone payments, and royalties on net sales. oncgnostics is one of the few diagnostic companies with a strong focus on applications in gynecological cancers, including cervical cancer.

"We are pleased to work with oncgnostics, an up-and-coming player in women's health. With three successful epigenetic products based on MDxHealth's proprietary MSP technology and biomarkers on the market; our lead product ConfirmMDx® for Prostate Cancer, PredictMDx® for Glioblastoma (MGMT) and our licensee Exact Sciences' Cologuard® test for colorectal cancer screening, DNA methylation is a proven diagnostic tool for cancer detection," said Dr. Jan Groen, CEO of MDxHealth. "We are excited about oncgnostics epigenetic GynTect® test, which will aid in the diagnosis and treatment of women with cervical cancer."

About oncgnostics GmbH

Founded as a spin-off from the University Womens' Hospital Jena, oncgnostics focuses on in vitro diagnostic tests for the early and accurate detection of cancer utilizing proprietary epigenetic biomarkers. The diagnostic products will allow earlier detection of more cancer cases and thus contribute to the improvement of therapeutic success. The initial product developed, GynTect®, allows for the rapid and reliable detection of cervical precancerous lesions and cancer. Through strategic alliances with other industry leaders, oncgnostics aims to extend its reach around the world. More information is available at www.oncgnostics.com and through contact@oncgnostics.com.

Vertraagd	1 jan 0001
Koers	0,000
Verschil	0,000 (0,00%)
Hoog	0,000
Laag	0,000
Volume	0
Volume gemiddeld	0
Volume gisteren	0

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