# Astute Medical

Astute Medical, Inc. was a San Diego in vitro diagnostics company founded in 2007 by former Biosite executives Christopher Hibberd and Paul McPherson, best known for the FDA-cleared NephroCheck test for early risk assessment of acute kidney injury (AKI); it has not been an independent company since bioMérieux acquired it for approximately $90 million in cash on April 4, 2018.<sup>[1](https://www.fiercehealthcare.com/healthcare/astute-medical-raises-6-2-million-series-a-financing-round-led-by-de-novo-ventures)</sup><sup> • </sup><sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup><sup> • </sup><sup>[3](https://www.reuters.com/article/business/healthcare-pharmaceuticals/biomerieux-acquires-astute-medical-inc-for-about-90-mln-in-cash-idUSL5N1RI0RN/)</sup>

| Fact | Detail |
|---|---|
| Founded | 2007<sup>[1](https://www.fiercehealthcare.com/healthcare/astute-medical-raises-6-2-million-series-a-financing-round-led-by-de-novo-ventures)</sup>, San Diego, CA (Delaware-incorporated; offices at 3550 General Atomics Court)<sup>[4](https://www.sec.gov/Archives/edgar/data/1432372/000143237216000002/xslFormDX01/primary_doc.xml)</sup> |
| Founders | Christopher Hibberd and Paul McPherson, former Biosite management<sup>[1](https://www.fiercehealthcare.com/healthcare/astute-medical-raises-6-2-million-series-a-financing-round-led-by-de-novo-ventures)</sup> |
| Sector | In vitro diagnostics, protein biomarker tests<sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup> |
| Lead product | NephroCheck, urinary TIMP-2 and IGFBP7 test for AKI risk<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup> |
| Total raised | $167,766,466 across 11 SEC Form D offerings, 2010–2016 (per an aggregator of the Form D filings; unverified against the underlying filings)<sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup> |
| Key investors | De Novo Ventures, Domain Associates, Delphi Ventures, JJDC, MPM Capital, Kaiser Permanente Ventures, CRG, Fosun Pharma, Bio-Techne; Ortho Clinical Diagnostics invested $15 million<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup><sup> • </sup><sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup> |
| Outcome | Acquired by bioMérieux for ~$90 million in cash, April 4, 2018<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup><sup> • </sup><sup>[3](https://www.reuters.com/article/business/healthcare-pharmaceuticals/biomerieux-acquires-astute-medical-inc-for-about-90-mln-in-cash-idUSL5N1RI0RN/)</sup> |

## History and founding

Astute Medical was founded in 2007 and led by Christopher Hibberd and Paul McPherson, both former members of the management of Biosite Incorporated, a diagnostics company acquired by Inverness Medical Innovations in 2007 for $1.68 billion<sup>[11](https://www.labmedica.com/industry-news/articles/245340000/in-turnabout-biosite-to-be-acquired-by-inverness-while-beckman-chooses-to-let-go.html)</sup>. Hibberd spent 10 years at Biosite, most recently as senior vice president of corporate development; McPherson spent 14 years there, most recently as vice president of research and development.<sup>[1](https://www.fiercehealthcare.com/healthcare/astute-medical-raises-6-2-million-series-a-financing-round-led-by-de-novo-ventures)</sup> At the time of acquisition, Hibberd was Astute's chief executive officer and McPherson its chief scientific officer.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup><sup> • </sup><sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup>

The company's board included figures from its filings and investor base: the 2010 Form D listed Hibberd and McPherson as executive officers and directors alongside directors Frederick Dotzler, Kim Blickenstaff, and Kenneth Buechler.<sup>[8](https://www.sec.gov/Archives/edgar/data/1432372/0001432372-10-000002.txt)</sup> Astute's early research interests spanned several acute-care conditions: abdominal pain, acute coronary syndrome, congestive heart failure, sepsis, cerebrovascular disease, and acute kidney injury.<sup>[1](https://www.fiercehealthcare.com/healthcare/astute-medical-raises-6-2-million-series-a-financing-round-led-by-de-novo-ventures)</sup> [Acute kidney injury](https://www.edgepedia.org/acute-kidney-injury) became its commercial focus.

## NephroCheck: what the test measures

NephroCheck is a urine-based test that measures two proteins, insulin-like growth factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases 2 (TIMP-2), biomarkers associated with cell-cycle arrest and kidney stress.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup><sup> • </sup><sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup> The test returns a risk score in about 20 minutes, indicating the likelihood that a patient will develop moderate or severe AKI within the next 12 hours.<sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup>

Its cleared intended use was narrow and specific: the test is used in conjunction with clinical evaluation in ICU patients who currently have, or have had within the past 24 hours, acute cardiovascular and/or respiratory compromise, as an aid in risk assessment for moderate or severe AKI within 12 hours.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup> The FDA described NephroCheck as a first-of-a-kind laboratory test intended to identify risk of moderate to severe AKI within 12 hours after testing, before conventional laboratory measures may confirm established injury.<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup> Astute's chief scientific officer also argued a specificity advantage: unlike many candidate AKI biomarkers, NephroCheck's markers are not typically elevated in chronic kidney disease or other syndromes common in ICU patients.<sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup>

## Funding and investors

Astute raised $167,766,466 in total across 11 SEC Form D offerings between 2010 and 2016, a figure from an aggregation of the Form D filings and unverified against the filings themselves.<sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup> Its first Form D, filed April 30, 2010, reported $635,000 sold of a $1,000,000 offering to 7 investors, signed by Hibberd as president and CEO.<sup>[8](https://www.sec.gov/Archives/edgar/data/1432372/0001432372-10-000002.txt)</sup>

Round by round, the record runs as follows<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup>:

- $6.25 million Series A, announced May 1, 2008, led by De Novo Ventures.<sup>[1](https://www.fiercehealthcare.com/healthcare/astute-medical-raises-6-2-million-series-a-financing-round-led-by-de-novo-ventures)</sup>
- $26.5 million Series B, May 10, 2010, co-led by Domain Associates and Delphi Ventures with Johnson & Johnson Development Corporation, filed as $26,560,375.<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup><sup> • </sup><sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup>
- $13.0 million Series B extension, March 8, 2011.<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup>
- $40.4 million Series C, announced June 7, 2012, led by MPM Capital with new investor Kaiser Permanente Ventures, filed as $40,449,738, intended to begin commercializing the first product.<sup>[9](https://www.prnewswire.com/news-releases/astute-medical-completes-404-million-series-c-financing-157764095.html)</sup><sup> • </sup><sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup>
- Debt financing along the way, including a CRG term loan of up to $30.0 million with up to $10.0 million more on revenue milestones (October 13, 2014) and smaller Form D debt tranches such as $4,984,083 (January 2014) and $2,000,200 (May 2012).<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup><sup> • </sup><sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup>
- $20.0 million strategic financing from Fosun Pharma, October 12, 2015, filed as $19,999,999 on September 30, 2015.<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup><sup> • </sup><sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup>
- A final Form D dated November 2, 2016 reporting $2,000,200 in debt plus options and warrants to 13 investors, signed by CFO Todd Myers.<sup>[4](https://www.sec.gov/Archives/edgar/data/1432372/000143237216000002/xslFormDX01/primary_doc.xml)</sup>
- $43.0 million strategic equity financing led by [Bio-Techne](https://www.edgepedia.org/bio-techne) with certain existing investors, December 14, 2016, filed as $43,032,359.<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup><sup> • </sup><sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup>

Separately from the Form D record, Ortho Clinical Diagnostics made a $15 million equity investment in Astute under a sales and licensing agreement covering the NephroCheck test and the Astute 140 Meter device in the EU and US, with Ortho serving as exclusive US sales agent.<sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup>

## Clinical evidence and regulatory path

The test received a CE mark in 2012 and European sales launched that year, and 360Dx reported that the FDA cleared it in 2014, after which Astute formed a distribution partnership in China.<sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup><sup> • </sup><sup>[10](https://www.360dx.com/business-news/biom-rieux-acquires-biomarker-discovery-firm-astute-medical-90m)</sup> At US clearance, Astute planned to hire around 25 sales and marketing personnel, bringing headcount to about 75.<sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup>

Claims about accuracy differ in kind. Paul McPherson, speaking for the company, said the test identifies patients who go on to develop AKI with an accuracy of around 90 percent.<sup>[5](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)</sup> A Clinical Kidney Journal review summarized the scientific rationale for the TIMP-2/IGFBP7 marker pair while cautioning that clinical impact and outcome benefit were still not fully proven.<sup>[7](http://biobase.whitefordresearch.com/companies/astute-medical)</sup> The strongest published outcome result cited at acquisition was a study in Intensive Care Medicine reporting a 33.9 percent reduction in the occurrence of moderate to severe AKI following cardiac surgery when clinicians used NephroCheck to identify at-risk patients and then implemented a bundle of care recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup> The context was large: bioMérieux cited estimates that up to 50 percent of severely ill hospitalized patients develop AKI, which can lead to prolonged hospital stays, chronic kidney disease, and higher costs of care.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup>

## Acquisition by bioMérieux and outcome

On April 4, 2018, bioMérieux announced it had agreed to acquire all shares of Astute Medical for approximately $90 million in cash, a deal Reuters reported the same day.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup><sup> • </sup><sup>[3](https://www.reuters.com/article/business/healthcare-pharmaceuticals/biomerieux-acquires-astute-medical-inc-for-about-90-mln-in-cash-idUSL5N1RI0RN/)</sup> The acquisition built on a 2015 partnership in which Astute granted bioMérieux a license to develop and market NephroCheck; bioMérieux said it intended to continue investing in health economic and outcome studies for the test and to explore other biomarkers in Astute's pipeline.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup>

The arithmetic of the exit: the ~$90 million purchase price was roughly half the $167.8 million investors had sold in securities across the Form D filings, a gap no source in this record explains.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup><sup> • </sup><sup>[6](https://www.dealdata.net/company-profile/0001432372/)</sup> bioMérieux separately estimated that Astute-related operating expenses for the remaining nine months of 2018 could reduce its 2018 contributive operating income by 60 basis points.<sup>[2](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)</sup>

## References

1. [Fierce Healthcare: Astute Medical Raises $6.2 Million in Series A](https://www.fiercehealthcare.com/healthcare/astute-medical-raises-6-2-million-series-a-financing-round-led-by-de-novo-ventures)
2. [bioMérieux press release: acquisition of Astute Medical (April 4, 2018)](https://www.biomerieux.com/content/dam/biomerieux-com/investor/regulated-informations/2018/releases/pr_biomerieux_-_acquisition_of_astute_-_20180404_0.pdf)
3. [Reuters: Biomerieux Acquires Astute Medical Inc. For About $90 Mln In Cash](https://www.reuters.com/article/business/healthcare-pharmaceuticals/biomerieux-acquires-astute-medical-inc-for-about-90-mln-in-cash-idUSL5N1RI0RN/)
4. [SEC Form D, Astute Medical, Inc. (filed 2016-11-16)](https://www.sec.gov/Archives/edgar/data/1432372/000143237216000002/xslFormDX01/primary_doc.xml)
5. [GenomeWeb: Astute Medical Receives FDA Clearance for NephroCheck Test](https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch)
6. [DealData: Astute Medical, Inc. SEC Form D filing record](https://www.dealdata.net/company-profile/0001432372/)
7. [Whiteford Research Biobase: Astute Medical](http://biobase.whitefordresearch.com/companies/astute-medical)
8. [SEC Form D, Astute Medical Inc. (filed 2010-04-30)](https://www.sec.gov/Archives/edgar/data/1432372/0001432372-10-000002.txt)
9. [PRNewswire: Astute Medical Completes $40.4 Million Series C Financing](https://www.prnewswire.com/news-releases/astute-medical-completes-404-million-series-c-financing-157764095.html)
10. [360Dx: BioMérieux Acquires Biomarker Discovery Firm Astute Medical for $90M](https://www.360dx.com/business-news/biom-rieux-acquires-biomarker-discovery-firm-astute-medical-90m)
11. [In turnabout biosite to be acquired by inverness while beckman chooses to let go (labmedica.com)](https://www.labmedica.com/industry-news/articles/245340000/in-turnabout-biosite-to-be-acquired-by-inverness-while-beckman-chooses-to-let-go.html)

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*Initially written Sep 17, 2026 · Reviewed: Sep 30, 2026 · Edited: Sep 30, 2026; Oct 11, 2026 · Last review: Sep 30, 2026*

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