Breaking News
Get Actionable Insights with InvestingPro+: Start 7 Day FREE Trial Register here
Investing Pro 0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

BioPorto Diagnostics: Key Leadership Changes Announced

By Edison GroupStock MarketsOct 21, 2021 12:31
uk.investing.com/analysis/bioporto-diagnostics-key-leadership-changes-announced-200500189
BioPorto Diagnostics: Key Leadership Changes Announced
By Edison Group   |  Oct 21, 2021 12:31
Saved. See Saved Items.
This article has already been saved in your Saved Items
 

BioPorto has announced the appointment of Anthony Pare and Neil Goldman as its new CEO and CFO, respectively, with effect from mid-November 2021. In addition, Thomas Magnussen, chairman of the Board of Directors, has decided to step down from his position, with vice chairman Christopher Lindop taking over. We note that both the CEO and CFO are US-domiciled and view these appointments as strategic given the company’s increasing focus on the US market as it inches closer to the completion of clinical trials and a subsequent de novo filing for its NGAL Test in paediatric patients.

EPS Estimates
EPS Estimates

Share price performance

Share Price Performance
Share Price Performance

Business description

BioPorto Diagnostics is a diagnostic company focused on the development and commercialisation of biomarker-based assays. Its portfolio includes the NGAL Test, for prediction of acute kidney injury, and an extensive antibody library. The company is currently undertaking clinical trials in paediatric patients, which are expected to conclude by the end of 2021, followed by the 501(k) de novo FDA filing. Approval in paediatric patients would be followed by studies in the adult population.

Both the new CEO and CFO come with strong technical and leadership backgrounds, with decades of executive experience between them. Incoming CEO Anthony Pare previously served as chief commercial officer of T2 Biosystems, an in vitro diagnostics company, and CFO Neil Goldman joins from Chembio Diagnostics, a global developer of point-of-care tests for infectious disease, having served as its CFO. Both companies are NASDAQ-listed.

The new appointments come at a critical juncture for BioPorto, as it is at a vital transition phase. The new United States-based appointments confirm the company’s increasing focus on progressing the NGAL Test to commercialisation as it approaches clinical approval, with the US being the key market.

BioPorto is approaching a key inflection point in its path to commercialisation. By the end of 2021, it expects to complete the pivotal study assessing its NGAL diagnostic test in critically ill paediatric patients at risk of moderate to severe acute kidney injury (AKI). BioPorto recently completed interim analysis of data (from six US children’s hospitals over a 12-month period) from the paediatric clinical trials and, while the data have not been made public, the company states that the results (in terms of sensitivity and specificity) were encouraging and support further enrolment and conclusion of the study. BioPorto is currently expanding patient enrolment to maximise the study’s statistical power and intends to onboard a further three partner hospitals to its existing 12 sites. Following conclusion of the clinical study, the company plans to apply for regulatory submission to the FDA for de novo 510(k) clearance in early 2022. In our experience, approvals in this category typically take three to six months, which could point to FDA approval as soon as Q2/Q322. Based on the results of the paediatric application, BioPorto will decide on the roadmap for the clinical studies and subsequent approval for the adult NGAL Test, a meaningfully larger market for the company.

BioPorto Diagnostics: Key Leadership Changes Announced
 

Related Articles

BioPorto Diagnostics: Key Leadership Changes Announced

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind: 

  • Enrich the conversation
  • Stay focused and on track. Only post material that’s relevant to the topic being discussed.
  • Be respectful. Even negative opinions can be framed positively and diplomatically.
  •  Use standard writing style. Include punctuation and upper and lower cases.
  • NOTE: Spam and/or promotional messages and links within a comment will be removed
  • Avoid profanity, slander or personal attacks directed at an author or another user.
  • Don’t Monopolize the Conversation. We appreciate passion and conviction, but we also believe strongly in giving everyone a chance to air their thoughts. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
or
Sign up with Email