Study to Evaluate the Safety and Activity of BB3 to Treat Heart Attack

Percutaneous coronary intervention (PCI) has become the mainstay for treatment of ST-segment
elevation myocardial infarction (STEMI). Whereas early recanalization undoubtedly salvages
myocardial tissue, reperfusion following prolonged ischemia can also exacerbate injury.
Infarct size needs to be limited, and the conditions favoring adaptive ventricular healing
and remodeling optimized because in patients with acute myocardial infarction (AMI) who do
not die of out-of-hospital arrhythmias, long-term prognosis is dependent on the amount of
myocardium that is lost, and the outcome of ventricular remodeling. Angion Biomedical
Corp. has identified BB3, a small molecule mimetic of hepatocyte growth factor/scatter
factor (HGF/SF) whose activity is expected to preserve tissue viability and attenuate
dysfunction in the setting of organ injury while obviating the logistical difficulties
associated with gene or protein therapy. HGF/SF is a naturally occurring cell survival
factor that holds significant therapeutic potential. BB3 has been shown to possess HGF/SF
activities, including protection against heart injury following myocardial infarction. This
study is designed to evaluate clinical efficacy of BB3 in patients presenting with acute ST
segment elevation myocardial infarction (A-STEMI) who undergo PCI.

Inclusion Criteria:

1. Signed informed consent

2. Estimated body weight < 120 kg and BMI < 30

3. Subject is experiencing clinical symptoms consistent with acute myocardial infarction
(AMI)

4. Fulfills clinical center's criteria for primary PCI

5. The subject and his/her physician are willing to comply with the requirements of the
study and the specified follow-up evaluations.

6. If female, either surgically sterile or post-menopausal or using acceptable
contraception and agree to use effective birth control regimen during the study
period. Men must agree to use condoms during the study period. Women of child
bearing potential must have a negative urine or serum pregnancy test.

7. In the opinion of the Investigator, the subject is capable of understanding and
complying with the protocol.

Exclusion Criteria:

1. Pregnant or nursing subjects and those who plan pregnancy in the period up to 6
months following index procedure.

2. Cardiogenic shock (Killip class 4) or cardiac arrest

3. History of prior myocardial infarction or pre-existing Q waves on ECG

4. An elective surgical procedure is planned that would necessitate interruption of
anti-platelet agents during the first six months post enrollment;

5. Any contraindication to undergo MRI imaging.

6. Subject has active bleeding or a history of bleeding diathesis or coagulopathy
(including heparin induced thrombocytopenia), or refusal to receive blood
transfusions if necessary;

7. Subjects presenting with cardiogenic shock or cardiopulmonary resuscitation prior to
randomization;

8. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic
stroke; stroke or transient ischemic attack within the past 6 months, or any
permanent residual neurologic defect; known preceding cardiac ventricular arrhythmia

9. Impaired renal function or on dialysis.

10. Impaired hepatic function

11. Currently participating in or has participated in an investigational drug or medical
device study within 30 days or 5 half-lives, whichever is longer, prior to enrollment
into this study

12. Have an active malignancy or history of solid, metastatic, or hematologic malignancy
with the exception of basal or squamous cell carcinoma of the skin that has been
removed

13. History of positive human immunodeficiency virus (HIV) test

14. History of rheumatoid arthritis